Reported trial results for Sleep Disorders

112 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT07598123 · results posted 16 July 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 40 in a multi-component group exercise program and 40 in a routine community activities group. The trial was measuring several aspects of physical fitness in older adults, including walking speed, leg strength, arm strength, hand grip strength, and balance. All 80 participants completed the baseline (starting) assessments. By the end of the trial, 36 out of 40 people finished in the exercise group and 39 out of 40 finished in the community activities group. The reported data shows the following numbers at the end of the trial (post-test). For the walking test (time to walk 4 metres), the exercise group averaged 3.91 seconds and the community activities group averaged 4.07 seconds; lower times mean faster walking. For the chair stand test (time to complete five sit-to-stands), the exercise group averaged 9.43 seconds and the community activities group averaged 9.36 seconds. For the 30-second arm curl test (number of arm curls completed), the exercise group averaged 25 repetitions compared to 21 in the community activities group. For grip strength, the exercise group averaged 26 kg versus 24 kg in the community activities group. For the two balance tests — standing side-by-side and standing heel-to-toe — the reported data shows the side-by-side test reached the maximum of 10 seconds in both groups, while the heel-to-toe test showed the exercise group averaging 6 seconds and the community activities group averaging 7 seconds at post-test. It is worth noting that the data as submitted does not clearly label which measurements belong to the baseline (start) and which belong to the post-test (end) time points for each outcome, so the figures above reflect the reported values as they appear in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06050720 · results posted 13 May 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people who had been identified as having a possible sleep disorder. Of those, 38 completed the study and 2 did not finish. The trial was designed to compare two devices used to measure something called the Apnoea Hypopnoea Index (AHI) — a count of the number of times per hour a person's breathing pauses or becomes very shallow during sleep. Participants wore both devices at the same time, overnight, in their own homes, so the readings from each device could be directly compared. The reported data shows that the primary measurement was a "correlation coefficient" of 0.955 between the trial device (ApneScan) and the established comparison device (NOX T3). A correlation coefficient is a number between 0 and 1 that describes how closely two sets of measurements move together — with 1 being a perfect match. The reported figure of 0.955 means the two devices produced very similar readings when worn at the same time. For the secondary outcome measures — which looked at the severity of sleep apnoea and the severity of episodes of shallow breathing — no numerical results were included in the data submitted to ClinicalTrials.gov, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT07384364 · results posted 25 March 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants in a single group, all receiving the same intervention. Of those, 16 completed the study and 3 did not finish. The trial was measuring changes in four things: how quickly and steadily people could move (using a timed walking test), how much back pain they reported, how well they slept, and how many times they could stand up and sit down in 30 seconds as a measure of leg strength. The reported data shows the following percentage changes from the start of the trial to the end. On the timed walking test (where a lower time means better movement), participants' times decreased by an average of about 23%. For self-reported back pain on a 0–10 scale, scores decreased by an average of about 67%, meaning participants reported lower pain scores. For sleep quality — rated on a 0–5 scale where higher is better — scores decreased by about 34%, which the trial notes as a negative direction on that scale (the data did not include a further breakdown to clarify this figure). For the sit-to-stand leg strength test, the number of repetitions completed increased by an average of about 61%. It is worth noting that this trial had a small number of participants and used only one group with no comparison group, which limits how broadly any numbers can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05194735 · results posted 10 November 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants in total — 1 person assigned to the lowest dose group (Dose Level 1) and 13 people assigned to the middle dose group (Dose Level 2). No participants were enrolled in the highest dose group (Dose Level 3). The trial was testing a type of cell therapy called TCR-T cell therapy, where a person's own immune cells are collected, modified in a laboratory, and then given back to them. The trial was primarily looking at what unwanted health events (called "adverse events") occurred after the treatment, whether any particularly serious reactions — called "dose-limiting toxicities" — were observed, and what the best dose might be going forward. The reported data shows that all 8 participants who actually received the cell infusion experienced at least one treatment-related adverse event — 1 in the Dose Level 1 group and 7 in the Dose Level 2 group. According to the reported data, no participants in either group experienced a "dose-limiting toxicity" (a pre-defined serious reaction within the first 28 days). Because of the small number of participants and the way the trial unfolded, no recommended dose for future studies was determined — the result for that measure was reported as "not applicable." The reported data also shows that, as a secondary measure, the modified cells could be detected in participants' blood after infusion, but the numbers dropped substantially by Day 28 — falling by about 91% from their peak in the Dose Level 1 group and about 97% in the Dose Level 2 group. It is also worth noting that of the 14 people who started the trial, only 8 went on to receive the cell infusion, with several participants not completing all steps — for example, some products could not be manufactured successfully or participants did not proceed to infusion. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05780983 · results posted 30 October 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants in a single group who received education and coaching aimed at developing healthy nighttime sleep and daytime activity behaviours. Six of the seven participants completed the study, and one did not finish. The trial was measuring several aspects of sleep and daily physical activity, including how efficiently participants were sleeping, how severe any sleep difficulties were, how many steps they were taking each day, and how much their sleep was disturbing their daily life. The reported data shows that, at the end of the study, participants' average sleep efficiency — that is, the percentage of time spent actually asleep while in bed, measured by a wrist device — was reported as 95.1%. For the insomnia severity score (a questionnaire where higher numbers, up to 28, mean more severe sleep difficulties), the average reported score was 9.67. The reported average number of daily steps taken was 5,188. On another sleep questionnaire measuring how much sleep problems were interfering with day-to-day life (scored from 0 to 6, where higher means more disruption), the average reported score was 1.2. No data comparing these figures to a before-and-after baseline or to a control group was included in the submitted results. It is worth noting that this was a very small study with only seven participants and no comparison group, which means the reported numbers reflect only this small group's experience during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03858309 · results posted 29 October 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people across two groups — 11 in Breathing Group 1 and 10 in Breathing Group 2. The study was measuring the flow of cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) using MRI scans, to see how different breathing practices were associated with the speed and direction of that fluid movement. It also tracked blood pressure, body mass index (BMI), and how often and how long participants did their breathing exercises at home. By the end of the study, 9 people in Group 1 and 7 in Group 2 had completed it, and the fluid flow results were based on 7 participants from each group who had usable MRI data from both visits. The reported data shows that cerebrospinal fluid speeds — measured at a specific point at the base of the skull — were similar across both groups and both time points. Fluid moving upward toward the brain was recorded at around 1.36–1.48 cm/s for Group 1 and 1.15–1.31 cm/s for Group 2 across the two visits. Fluid moving downward was recorded at around −1.68 to −1.92 cm/s for Group 1 and −1.73 to −1.84 cm/s for Group 2. For blood pressure, the reported data shows Group 1 averaged around 128/80 mmHg before and 126/76 mmHg after, while Group 2 averaged around 118/66 mmHg before and 118/63 mmHg after. BMI stayed very similar across both groups between visits. Home practice frequency was reported at around 5 days per week for both groups, with average session durations of roughly 20–22 minutes. The researchers noted that these figures are descriptive only — meaning they are a straightforward summary of the numbers, and no formal statistical comparisons were included in this registry submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04171037 · results posted 24 July 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 108 people in total — 54 in a group that received oxygen through a device called Optiflow™ THRIVE (a type of high-flow nasal oxygen) and 54 in a control group that received oxygen through a standard face mask. The trial was looking at what happened to patients' oxygen levels during a 60-minute window while they were given a sedation medication called propofol. Specifically, it was measuring how often and for how long patients' blood oxygen levels dropped to a low level (92% or below), which researchers called a "desaturation episode." The reported data shows that, for the main outcome, patients in the Optiflow™ THRIVE group spent a combined total of 34 minutes experiencing low oxygen episodes, compared with 97 minutes for the face mask group. For the secondary outcomes, the reported data shows that 7 participants in the Optiflow™ THRIVE group had at least one low oxygen episode, compared with 13 in the face mask group. The trial also tracked episodes where a brain-activity monitoring score suggested sedation may not have been deep enough — 2 such episodes were recorded in the Optiflow™ THRIVE group versus 4 in the face mask group. Finally, the reported data shows that patients in the Optiflow™ THRIVE group spent an average of 20 minutes in the post-procedure recovery area, compared with 26 minutes for the face mask group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04154631 · results posted 4 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04154631) involved 489 people across two groups — 175 in the "Standard TranS-C" group and 314 in the "Adapted TranS-C" group. Within each group, participants were either offered the sleep treatment straight away ("Immediate") or placed in a delayed treatment comparison condition ("UC-DT"). The trial also included healthcare providers (30 in the Standard group, 63 in the Adapted group). The study was measuring sleep disturbance, sleep-related impairment, and overall sleep health in patients, as well as how acceptable providers found the treatment approach. A total of 133 participants in the Standard group and 261 in the Adapted group completed the study. The reported data shows that, for the main patient sleep measure (a standardised sleep disturbance score where 50 represents the general population average and higher numbers mean more disturbed sleep), patients in both immediate-treatment groups started with scores around 62–64 at the beginning of the trial. Those who received the treatment straight away had scores that moved closer to the population average over time — dropping to around 53–54 at one follow-up point and around 50–52 at a later point — while those in the delayed comparison condition remained around 61 at that same later point. For the provider acceptability measure (scored 1 to 5, with 5 meaning completely acceptable), providers in both groups reported scores of approximately 4.6 to 4.7 across all time points. On the secondary measures, the reported data shows broadly similar patterns: scores relating to daytime tiredness, overall sleep health, daily functioning, and broader mental health symptoms all showed numerical changes across the time points for the groups who received immediate treatment, compared with smaller changes in the delayed comparison groups. The specific numbers for some time points and subgroups were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05594589 · results posted 3 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05594589) looked at a sleep medication called lemborexant, tested at two doses (5 mg and 10 mg), compared with a placebo (a dummy pill with no active ingredient). A total of 65 people entered an initial placebo run-in phase, after which 13 were assigned to continue with placebo, 26 to lemborexant 5 mg, and 26 to lemborexant 10 mg. Nearly all participants completed the study — one person in the lemborexant 5 mg group did not finish. The trial measured two main things related to sleep: how long it took participants to fall asleep (called "latency to persistent sleep"), and how efficiently they slept (the proportion of time in bed actually spent asleep). These were measured using specialised overnight sleep monitoring equipment. The reported data shows that, by day 30, the time it took to fall asleep had decreased in all three groups compared to where they started. The placebo group's fall-asleep time dropped by about 46 minutes on average. The lemborexant 5 mg group's fall-asleep time dropped by about 51 minutes, and the lemborexant 10 mg group's dropped by about 44 minutes. For sleep efficiency (the percentage of time in bed spent asleep), the placebo group showed an average increase of around 8 percentage points, while both the lemborexant 5 mg and 10 mg groups showed increases of roughly 15 percentage points. These are the changes from each person's starting point, not absolute sleep times, so they reflect how much things shifted over the course of the trial. The reported data also shows that, during the treatment period, adverse events (unwanted health changes that occurred during treatment) were recorded in 1 out of 13 placebo participants, 5 out of 26 in the lemborexant 5 mg group, and 2 out of 26 in the lemborexant 10 mg group. No participants in any of the three groups were reported to have clinically significant abnormal results on laboratory tests (such as blood or urine tests). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04532749 · results posted 4 June 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called seltorexant in people experiencing depression with sleep disturbance. A total of 212 participants were enrolled — 107 received seltorexant and 105 received a placebo (a dummy pill with no active ingredient) — over a treatment period of about six weeks (Day 1 to Day 43), followed by a two-week follow-up period. The trial measured changes in depression severity and sleep disturbance using several standardised questionnaires, where lower scores over time indicated fewer symptoms. The reported data shows that for the main measure — a 10-item depression rating scale called the MADRS (scored 0–60, with higher scores meaning more severe symptoms) — the seltorexant group's average score fell by 14.0 points from their starting score, while the placebo group's average score fell by 13.1 points. For a separate sleep disturbance questionnaire (called PROMIS-SD, where a higher score means more disturbance), the seltorexant group's score dropped by an average of 13.7 points compared to 11.9 points in the placebo group. The reported data also shows that 42.9% of participants in the seltorexant group had their depression score cut by at least half by Day 43, compared with 36.3% in the placebo group. Scores on other depression questionnaires (including the PHQ-9, which participants filled in themselves) also showed reductions in both groups, with the seltorexant group consistently reporting slightly larger drops than the placebo group across all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06092710 · results posted 3 June 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 112 people in total — 52 in a study group who underwent a sleep monitoring test (called polysomnography, or PSG) along with a sleep survey, and 60 in a control group who completed the sleep survey only. All 112 participants finished the trial with no dropouts. The trial was testing a new questionnaire-style scale designed to measure how well a person can perceive changes in airflow through their nose, mouth, and throat, and whether scores on this scale could help identify people at risk of obstructive sleep apnoea (OSA — a condition where breathing is repeatedly interrupted during sleep). The reported data shows that on the first main measure — a simple airflow perception score out of 7 — the study group scored an average of 5 and the control group scored an average of 4. On the second main measure, which used a broader total score out of 26 combining airflow perception, physical signs, sleep habits, and questionnaire responses, the study group averaged 8.63 and the control group averaged 5.92. For the secondary outcome, which looked at whether scores could reflect OSA severity, the reported data shows that the intermediate score (out of 13) was 5.92 for controls, 8.78 for mild cases, 8.47 for moderate cases, and 8.75 for severe cases. The total score (out of 26) was 8.26 for controls, 12.89 for mild cases, 12.33 for moderate cases, and 13.61 for severe cases. It is worth noting that the trial description states it was designed to create and describe this scale, rather than to definitively validate it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05027438 · results posted 11 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05027438) enrolled 36 participants in a single group called "COAST + Deprescribing." The trial was measuring two main things: changes in insomnia severity (using a standard questionnaire called the Insomnia Severity Index, or ISI, scored from 0 to 28 where higher scores mean more severe insomnia) and changes in how much sleep medication participants were taking. It also tracked several sleep diary measures, including how long it took participants to fall asleep, how long they were awake during the night, and how efficiently they were sleeping. Of the 36 who started, 25 completed the main treatment phase, and 19 reached the final three-month follow-up point. The reported data shows that the average ISI score started at 14.63 (in the "sub-threshold" insomnia range), dropped to 6.13 at the end of treatment (in the "no insomnia" range), and was 7.17 at the three-month follow-up check. For sleep medication use, participants were reported to be taking about 41% of their original dose by the end of treatment and around 38% at follow-up — compared to 100% at the start. The reported data also shows that 7 participants had stopped taking sleep medication entirely by the end of treatment, rising to 12 participants at the three-month follow-up. On the sleep diary measures, the reported average time to fall asleep went from about 34 minutes at the start to around 20 minutes at both later time points; time spent awake during the night went from roughly 26 minutes down to about 11 minutes by follow-up; and sleep efficiency (a measure of how much time in bed was actually spent sleeping) was reported to go from 87% at the start to 94% at follow-up. It is worth noting that there was only one group in this trial — there was no separate comparison group — so the reported numbers reflect changes within the same group of participants over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03804788 · results posted 15 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03804788) enrolled 71 eligible participants who had both insomnia and risky drinking. They were split into two groups: 38 people received Cognitive Behavioural Therapy for Insomnia (CBT-I — a structured talking therapy aimed at changing thoughts and habits around sleep), and 33 people received Sleep Hygiene education (general advice about good sleep habits). All 71 participants completed the study. The trial was measuring whether it was practical to run — tracking how many people signed up and stayed, as well as monitoring changes in drinking levels, alcohol-related harms, insomnia symptoms, and sleep quality across three time points (the start of the study, end of treatment, and a later follow-up). The reported data shows the following numbers across the three time points (start, end of treatment, and follow-up). For **drinks per week**, the CBT-I group went from 18.63 to 15.29 to 15.12, while the Sleep Hygiene group went from 17.94 to 12.00 to 15.73. For **alcohol-related consequences** (scored 0–24, higher meaning more harms), the CBT-I group went from 7.92 to 2.45 to 3.31, and the Sleep Hygiene group went from 8.45 to 4.46 to 5.28. For **insomnia symptoms** (scored 0–28, higher meaning worse insomnia), the CBT-I group went from 17.29 to 7.24 to 6.97, and the Sleep Hygiene group went from 16.88 to 12.27 to 12.30. For **sleep quality** (scored 0–4, higher meaning better quality), the CBT-I group went from 1.92 to 2.49 to 2.53, and the Sleep Hygiene group went from 1.73 to 2.13 to 2.14. No data was reported about whether any of these differences between groups were statistically meaningful (that is, whether they were likely due to chance or not). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05299723 · results posted 7 January 2025

  According to the results reported on ClinicalTrials.gov, this was a small pilot trial (NCT05299723) that ran in two phases. It looked at a bright light therapy (BLT) intervention for sleep, and was designed to test whether the study itself was practical to run — not to prove whether the treatment works. A total of 19 people started the trial across three groups: 4 in an open-label phase (Phase A), 10 in an active treatment group (Phase B), and 5 in a sleep hygiene education comparison group (Phase B). Of those, 17 completed the study — 2 people in the active treatment group did not finish. The reported data shows the trial was primarily measuring things like how many participants completed all their questionnaires, and how the people who received the light therapy intervention rated it for feasibility (whether it seemed doable), acceptability (whether it seemed agreeable), appropriateness (whether it seemed suitable for improving sleep), and usability (how easy the device was to use). In the open-label Phase A group, all 4 participants completed their assessments, and all 4 met the target scores for feasibility, usability, and adherence (using the device on at least half of the days); 2 out of 4 met the target score for acceptability, and 3 out of 4 for appropriateness. In the active treatment group in Phase B, 7 out of 8 who completed the study met the questionnaire completion, feasibility, and usability targets; 5 out of 8 met the feasibility score cut-off, 4 out of 8 met the acceptability cut-off, and 2 out of 8 met the appropriateness cut-off. The sleep hygiene education comparison group was not given the intervention rating questionnaires, so those measures were not reported for that group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04739423 · results posted 2 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people across three groups: people with Parkinson's disease (PD), people with mild cognitive impairment (MCI), and people with Parkinson's disease dementia or a related condition called dementia with Lewy bodies (DDD or DLB). Participants were split into two sequences — meaning they received either an active treatment or a placebo (a dummy treatment) in a particular order. The trial was measuring things like how well people recognised emotions on faces, whether they experienced fluctuations in thinking and awareness, how their memory performed on computer-based tests, and what a wearable body sensor recorded about their sleeping heart rate and heart rate variability (small beat-to-beat changes in heart rhythm). The reported data shows that for the facial emotion recognition task, the percentage change figures varied across groups. For example, in the PD group, those who received the placebo showed a change of around −150.77% while those on the active treatment showed a change of around +16.52%; in the MCI group, the placebo group showed approximately −17.51% and the active group approximately −25.03%. For cognitive fluctuations in the smaller DDD or DLB group (which had very few participants — just one to two people per subgroup — making these numbers difficult to interpret meaningfully), the reported data shows small numbers of participants showing improvement across both placebo and active conditions. For the computer-based memory tests, word recall scores changed by small amounts across all groups, ranging from roughly −2.79 to +1.89 words. The wearable sensor data showed that sleeping heart rate changed by about −0.39 beats per minute in the overall placebo group and +4.67 beats per minute in the overall active group, while heart rate variability measures showed modest differences between placebo and active groups across the overall cohort. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04986904 · results posted 23 October 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 102 participants, all of whom used an online sleep program called SHUTi (Sleep Healthy Using the Internet). The trial was designed to look at how much participants actually engaged with the program, and to measure changes in their sleep-related thoughts and beliefs. All 102 participants were caregivers — people who look after someone else — and the study tracked them through a nine-week period. By the end of the study, 90 participants had fully completed it, while 12 did not finish. The reported data shows that when it came to engagement with the program, 18 out of 102 participants completed none of the program's modules (called "cores") and were classed as non-users; 22 completed between one and three cores and were classed as incomplete users; and 60 completed four to six cores, meaning they finished the full program. For the secondary outcomes, the trial measured sleep-related thoughts using a scale from 0 to 160 (where higher scores mean more unhelpful thinking about sleep). The reported data shows that at the start of the study, scores were similar across groups — around 92–93 for non-users and incomplete users, and 86 for complete users. Post-program scores were reported only for the two user groups: incomplete users scored 61.12 and complete users scored 54.82. The trial also measured participants' sense of control over their sleep. The reported data shows some variation in these scores across the three groups both before and after the program, though the data as submitted to ClinicalTrials.gov does not include a follow-up score for the non-user group on these secondary measures. It is worth noting that several other planned measures — including open-ended feedback, a program evaluation questionnaire, and a caregiving strain scale — had no numerical results reported in the data submitted to ClinicalTrials.gov, so those findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00581009 · results posted 17 October 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 49 people who had been diagnosed with depression. Participants were split into two groups: 17 people received medication only, and 32 people received medication combined with what the researchers called "chronobiological augmentation" — a type of treatment that works with the body's natural daily rhythms (such as sleep-wake cycles and light exposure). All 49 participants completed the study. The trial was measuring changes in depression symptom severity over the first 7 days and up to 7 weeks of treatment, using a standard questionnaire called the Hamilton Rating Scale for Depression (HRSD). This 21-item scale runs from 0 to 66, where a higher number means more severe depression symptoms. The reported data shows that at the start of the trial, both groups had similar average scores on the depression scale — 19 for the chronobiological augmentation group and 18.5 for the medication-only group. After the first 7 days, the reported average scores were 10.2 for the chronobiological augmentation group and 14.4 for the medication-only group. At the end of the full treatment period (up to 7 weeks), the reported average scores were 10.1 for the chronobiological augmentation group and 15.2 for the medication-only group. No other outcome measures were included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03968939 · results posted 16 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03968939) enrolled 55 people in total across three groups: 15 received usual care (the control group), 26 received sleep hygiene education, and 14 received over-the-counter sleep aids (25 mg of Benadryl plus 3 mg of melatonin). All 55 participants who started the study completed it. The trial was measuring three things across multiple time points: daytime sleepiness (using a questionnaire called the Epworth Sleepiness Scale, scored 0–24 where higher means more sleepiness), overall sleep quality (using a questionnaire called the Pittsburgh Sleep Quality Index, scored 0–27 where lower means better sleep quality), and self-reported pain (on a 0–10 scale where 0 is no pain and 10 is unbearable pain). The reported data shows the following scores across the measurement time points. For daytime sleepiness, scores across all three groups generally sat in the range of roughly 6 to 9 out of 24 throughout the study. For overall sleep quality, scores across the groups ranged from roughly 7 to 13 out of 27 at the various time points — with the over-the-counter sleep aids group recording scores of 6.81 and 7.33 at the later time points, compared to around 9–11 for the control group and 10–13 for the sleep hygiene education group at those same points. For pain, all three groups started with scores between roughly 4 and 6 out of 10, and the reported data shows scores in all groups were lower at later time points, sitting between approximately 1.8 and 2.78 out of 10 by the final measurement. It is important to note that the reported data does not include information about how these changes were analysed statistically (that is, whether any differences between groups were likely due to chance or not), and no such figures were available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02805998 · results posted 25 June 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02805998) enrolled 208 participants — 105 in a group that received a web-based form of Cognitive Behavioural Therapy for Insomnia (CBT-I, a structured talking-based program delivered online) and 103 who received their usual care. Of those, 91 and 94 participants respectively completed the study. The trial was measuring changes in sleep-related outcomes, including how severe participants rated their insomnia, how efficiently they slept, how long they slept, and their overall sleep quality. It also measured changes in depressive symptom scores. The reported data shows the following changes from the start of the trial to its end. For the main (primary) outcome — a standardised insomnia severity score out of 28, where higher means worse — the web-based CBT-I group reported an average decrease of about 6.1 points, while the usual care group reported an average decrease of about 2.2 points. For sleep efficiency (the proportion of time in bed actually spent asleep, expressed as a percentage), the web-based CBT-I group reported an average increase of around 8.3 percentage points, compared with about 0.3 percentage points in the usual care group. Sleep duration showed an average increase of roughly 0.34 hours in the web-based CBT-I group, while the usual care group reported a small average decrease of about 0.02 hours. On a general sleep quality scale (scored 0–21, higher meaning worse), the web-based CBT-I group reported an average decrease of about 3.2 points versus about 0.2 points in the usual care group. A depressive symptom scale (scored 0–30, higher meaning worse) showed an average decrease of roughly 2.2 points in the web-based CBT-I group and about 0.04 points in the usual care group. Finally, a scale used to assess whether participants met criteria for an insomnia diagnosis showed changes in both groups, though the reported data for this measure uses a scoring method that the trial itself notes can be difficult to interpret directly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02995837 · results posted 13 June 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 19 children diagnosed with Obstructive Sleep Apnea Syndrome (OSAS) — a condition where breathing repeatedly stops during sleep — and 15 children without the condition who acted as a comparison group (controls). The trial was measuring blood flow to the brain (called cerebral blood flow, or CBF) and how it responds when children breathe a mixture of oxygen and carbon dioxide, which is a way of testing how well the brain automatically adjusts its own blood supply. It also looked at thinking and behaviour skills over time. Of those who started, 10 children in the OSAS group and 7 in the control group completed the study, with 9 and 8 respectively not finishing. The reported data shows that, at the starting point of the trial, the average change in brain blood flow in response to the breathing challenge was 184% for children with OSAS and 209% for the control children. For the secondary measure — tracking how brain blood flow changed over roughly 6 to 12 months (after surgery to remove the tonsils and adenoids for the OSAS group, or over time for controls) — the reported rate of change was +0.013 percentage points per year for the OSAS group and −0.083 percentage points per year for the control group. The reported data also shows a correlation figure (a number describing how two things move together, ranging from −1 to +1) between sleep apnea severity and brain blood flow regulation: −0.0018 for the OSAS group and 0.37 for the control group. Finally, on a standardised thinking-skills questionnaire scored from 0 to 100 (where 50 is average and higher scores suggest more difficulty), the OSAS group scored 56.5 and the control group scored 49.7 on average. It is worth noting that the numbers above come from a relatively small group of children, and a substantial proportion did not complete the study, which the researchers acknowledged by limiting some analyses to those who attended two or more visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04364191 · results posted 29 May 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04364191) enrolled 27 people in total — 13 in the intervention arm and 14 in the control arm. Of those, 12 people in each group completed the study (one person left the intervention arm and two left the control arm). The trial measured two main things: how long it took participants to fall asleep (called "sleep latency"), and their self-reported general health and quality of life using a standard questionnaire (the SF-36, scored from 0 to 100, where a higher score means better quality of life). It also tracked a secondary measure — how many minutes people spent awake during the night after first falling asleep (called "wake after sleep onset," or WASO), recorded using a wrist-worn activity monitor. The reported data shows two sets of results, suggesting measurements were taken at two different time points. For time to fall asleep, the intervention arm reported averages of 28.51 minutes (first time point) and 25.39 minutes (second time point), while the control arm reported averages of 47.06 minutes and 35.92 minutes respectively. For general health quality of life, the intervention arm scored 60.83 and then 55.83 out of 100, compared with 58.08 and 54.58 for the control arm. For time spent awake during the night, the intervention arm reported averages of 29.57 minutes and then 29.30 minutes, while the control arm reported 37.25 minutes and 35.21 minutes. The data does not include information about whether these differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance), so that detail was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03664765 · results posted 12 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03664765) enrolled 24 people in total — 12 in the exercise intervention group (who undertook upper airway and respiratory muscle training) and 12 in a control group (who received a sham version of the training). The trial was primarily designed to test whether the study itself was practical to run — specifically, whether participants could be recruited and whether they could complete a three-month programme. This type of trial is sometimes called a "feasibility" study, meaning its main purpose was to check if a larger trial would be workable, rather than to test whether a treatment works. The reported data shows that, of the 24 people who started the trial, 8 out of 12 in the exercise group and 10 out of 12 in the control group completed the full three-month protocol. In the exercise group, 4 participants did not complete the study, while 2 did not complete it in the control group. Regarding recruitment, the reported data shows that 29 people from the eligible pool were recruited into the study across both groups. No other outcome measures — such as any health or symptom results — appear to have been reported in the structured data submitted to ClinicalTrials.gov. It is worth noting that because this was a feasibility study with a small number of participants, it was not designed to draw broad conclusions about the training programme itself. The reported figures simply describe how the trial ran. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02988375 · results posted 12 January 2024

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of people who had both insomnia and depression. One group (946 people) received a digital form of Cognitive Behavioural Therapy for Insomnia (dCBTI — an online sleep therapy programme), and the other group (439 people) received sleep education materials. Of those who started, 358 people in the dCBTI group and 300 people in the sleep education group completed the study. The trial was measuring the severity of depression symptoms and the severity of insomnia symptoms at the start, after treatment, and again one year later. The reported data shows that at the start of the trial, both groups had very similar depression scores on the QIDS scale (which runs from 0 to 27, where higher means more severe) — both groups averaged 10.8. After treatment, the dCBTI group's average score was reported as 3.9, while the sleep education group's average score was 6.4. At the one-year follow-up, the dCBTI group averaged 4.7 and the sleep education group averaged 6.5. For insomnia severity (measured on the ISI scale, ranging 0 to 28), both groups started at around 17.8 and 17.7 respectively. The reported post-treatment insomnia scores were 17.9 (dCBTI) and 17.7 (sleep education) — noting these figures appear very similar to the starting scores. At the one-year mark, the dCBTI group's average insomnia score was reported as 8.2, compared with 12.8 for the sleep education group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04570150 · results posted 5 January 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 90 adults who were having surgery and needed muscle-relaxing medication as part of their anaesthetic. All 90 participants completed the study — 45 received a drug called sugammadex and 45 received a drug called neostigmine, both of which are used to reverse the effects of muscle relaxants at the end of surgery. The trial was measuring how quickly people were ready to leave the post-anaesthesia care unit (PACU — the recovery room after surgery), as well as how their breathing was affected after the operation compared to before it. The reported data shows that, for the main outcome, people in the sugammadex group were recorded as being ready to leave the recovery room after a median (middle value) of 123 minutes, compared to 125 minutes in the neostigmine group. For the breathing-related outcomes, the trial tracked several measures of lung function and blood oxygen levels before and after surgery, and reported the results as a proportional change (a number between 0 and 1, where 1 would mean no change from before surgery). The reported data shows that peak expiratory flow (how fast air can be breathed out) changed to 0.57 of its pre-surgery level in the sugammadex group and 0.65 in the neostigmine group. The volume of air exhaled in one second (FEV1) changed to 0.63 and 0.73 respectively, while total lung capacity (FVC) changed to 0.62 and 0.72. For blood oxygen levels (PaO2), the proportional change was 0.74 in the sugammadex group and 0.90 in the neostigmine group. Carbon dioxide levels in the blood (PaCO2) showed a proportional change of 1.08 in the sugammadex group and 1.07 in the neostigmine group, meaning both groups' carbon dioxide levels were slightly above their pre-surgery baseline after the operation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03658954 · results posted 13 November 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 120 people in total across three groups. One group of 30 received general advice only, a second group of 30 received advice plus tools to track their own sleep (self-monitoring), and a third group of 60 received advice, self-monitoring, and personalised feedback. The trial was measuring how much alcohol participants drank over a 12-week follow-up period, as well as looking at sleep quality, sleep-related daytime difficulties, and how satisfied participants were with their treatment. Most participants completed the study — only 2 people across all three groups did not finish. The reported data shows that alcohol consumption (measured on a log scale, a mathematical way of handling a wide range of numbers) was 3.07 for the advice-only group, 2.95 for the advice plus self-monitoring group, and 2.96 for the advice plus self-monitoring plus feedback group. For sleep disturbance (scored on a scale where 50 is average and 60 or above is considered clinically significant), the reported averages across follow-up were 51.39, 49.75, and 49.46 for the three groups respectively. For sleep-related daytime impairment, the reported averages were 57.80, 57.05, and 54.89. Satisfaction with treatment was rated on a 0–4 scale, with scores of 3.45, 3.48, and 3.60 reported for the three groups. It is also noted that a planned test of reaction time was discontinued due to COVID-19, and the data from participants who completed it before that point was not used in the main analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04974515 · results posted 16 October 2023

  According to the results reported on ClinicalTrials.gov, this trial looked at a device called eXciteOSA, which is a mouthpiece-style device intended for people with sleep apnoea. A total of 40 people took part — 19 in a lower-intensity group and 21 in a higher-intensity group — and all 40 completed the study. The trial was primarily measuring how consistently participants used the device over the study period, and also tracked several measures related to breathing during sleep, daytime sleepiness, sleep quality, and quality of life. The reported data shows that, on average, participants in both groups used the device on a very similar number of days — around 38 days in the low-intensity group and 38.4 days in the high-intensity group. For breathing disruptions during sleep (measured as the number of abnormal breathing events per hour), the low-intensity group recorded an average of 12.6 events per hour and the high-intensity group recorded 9.6 events per hour. On a daytime sleepiness questionnaire (scored 0–24, where higher means sleepier), the low-intensity group scored 9.4 and the high-intensity group scored 6.9. For sleep quality (scored 0–21, where higher means worse), scores were 7.2 and 5.5 respectively. On a general quality-of-life scale (scored 0–100, where higher means better), the low-intensity group scored 76.6 and the high-intensity group scored 86.5. A second quality-of-life measure (scored 0–1, where higher means better) showed scores of 0.88 and 0.84 for the low- and high-intensity groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04091438 · results posted 26 September 2023

  According to the results reported on ClinicalTrials.gov, this trial involved 28 people in total (14 in each group), though a small number did not complete all stages. It used a "crossover" design, meaning participants took turns receiving either the study drug TAK-925 (at a dose of 112 mg) or a placebo (an inactive treatment), with a washout period in between. The trial was primarily measuring how often participants experienced unexpected medical events or abnormal test results while taking the drug or placebo, and secondarily looking at how the drug moved through the body in the bloodstream. The reported data shows that when it came to unexpected medical events (called treatment-emergent adverse events), 40.0% of participants experienced at least one while receiving TAK-925, compared with 14.8% while receiving the placebo. For abnormal laboratory test results, 3.7% of participants had a markedly abnormal result under placebo, while 0% did under TAK-925. Reported figures for heart tracing (ECG) and vital signs measurements (such as blood pressure or heart rate) varied across different individual measurements, with most sitting between 0% and 14.8% across both groups. On the secondary measures, the reported data shows that the average concentration of TAK-925 in the blood at the end of the infusion was 222.0 nanograms per millilitre, and a measure of overall drug exposure over time was reported as 2,253 nanogram-hours per millilitre. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03745898 · results posted 1 August 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 98 people with heart failure — 48 received nocturnal oxygen therapy (oxygen delivered during sleep) and 50 received a sham version (a device that looked the same but delivered room air instead of extra oxygen). All 98 participants completed the study. The trial was set up to measure whether nocturnal oxygen therapy made a difference to serious heart-related events, quality of life, mood, and sleep compared to the sham treatment. The reported data shows that for the main outcome — the number of participants who experienced death from any cause, an unplanned hospital stay for worsening heart failure, or a life-saving heart procedure — 15 people in the oxygen group and 9 people in the sham group had at least one such event. When looking at the total count of all such events across the study (including repeat events per person), the oxygen group recorded 22 events and the sham group recorded 18 events. For quality of life, both groups showed improvements in their scores over the course of the trial on all questionnaires used. On the heart-failure-specific quality of life questionnaire (scored 0–100, higher is better), the oxygen group's score changed by 7.19 points and the sham group's by 4.83 points. On the general quality of life scale, changes were 0.06 and 0.02 respectively. For depressive symptoms (scored 0–24, lower is better), both groups' scores decreased — by 2.21 points in the oxygen group and 1.61 points in the sham group. Sleep-related scores also changed in both groups, with the oxygen group showing slightly larger reductions in sleep disturbance and daytime impairment scores than the sham group, though the reported data does not include statistical comparisons to indicate whether any of these differences between groups were considered meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04726514 · results posted 22 June 2023

  According to the results reported on ClinicalTrials.gov, this trial looked at a device called SleepFlex, which is a treatment for sleep apnoea — a condition where breathing repeatedly stops and starts during sleep. Ten people enrolled in the SleepFlex Treatment group, eight of whom completed the study and two did not finish. The trial measured two main things: whether participants experienced any serious device-related health events, and how their sleep apnoea severity changed before and after using the device. Severity was measured using something called the Apnea-Hypopnea Index, or AHI — a score that counts the average number of breathing interruptions per hour of sleep, where a score of 5–15 is considered mild, 15–30 moderate, and 30 or above severe. The reported data shows that all 10 participants were recorded as free from serious health events that were related to the SleepFlex device. For the AHI measure, the reported data shows a change of 2.9 breathing interruptions per hour between the before-treatment and after-treatment sleep tests (noting this is the average change across participants, not the final score itself). The reported data also shows additional measurements broken down by sleeping position: a change of 5.7 events per hour when participants slept on their back, and a change of 0.5 events per hour when sleeping in other positions. For the secondary outcome looking at side effects such as mouth, throat, or neck pain, or difficulty swallowing, the reported data shows that 0 out of 10 participants experienced these particular side effects. It is worth noting this was a very small study of only 10 people, so the numbers reflect a limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03359096 · results posted 30 March 2023

  According to the results reported on ClinicalTrials.gov, this trial looked at whether a device called hypoglossal nerve stimulation (HGNS) — an implanted device used for sleep apnoea — might have any effect on blood pressure. A total of 63 people were enrolled across two groups. The trial used a "crossover" design, meaning each person spent four weeks with the device turned up to its normal therapeutic level, and four weeks with it turned down to a very low "sham" (inactive-like) setting, with a one-week break in between. By the end of the trial, 60 people completed both intervention periods. The reported data shows that the main thing being measured was average 24-hour blood pressure (the top number, called systolic pressure, measured in mmHg — the standard unit for blood pressure). When participants were on the therapeutic setting, the reported average systolic blood pressure over 24 hours was 122.8 mmHg, compared with 123.0 mmHg on the sham setting — a difference of just 0.2 mmHg. For the bottom number (diastolic pressure), the reported figures were 71.9 mmHg (therapeutic) versus 72.1 mmHg (sham). Overnight blood pressure readings were also similar between the two settings: 115.0 vs 114.8 mmHg (systolic) and 65.8 vs 66.3 mmHg (diastolic). A separate measurement of heart-related timing (pre-ejection period) showed 105.7 milliseconds on therapeutic versus 105.4 milliseconds on sham. Two other measurements — nerve activity signals — were only collected from 7 participants at one site, and the trial itself notes there is insufficient data from those measures to draw any meaningful conclusions from those figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04033367 · results posted 2 November 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04033367) looked at the use of dupilumab (an injectable medicine) in people with atopic dermatitis (eczema) who also had problems with sleep. A total of 188 participants took part — 127 received dupilumab from the start, and 61 received a placebo (an inactive dummy treatment). The trial had two phases: a 12-week "double-blind" period (where neither participants nor researchers knew who was getting which treatment), followed by a 12-week open-label extension where everyone received dupilumab. The main thing being measured was how much participants' sleep quality scores changed over the first 12 weeks. The reported data shows that, for the main measure — sleep quality rated on a scale of 0 (worst) to 10 (best) — the dupilumab group reported an average decrease of about 47.7% from their starting score, compared to a decrease of about 33.0% in the placebo group. For itch intensity (rated 0–10, with 10 being worst), the dupilumab group reported an average reduction of around 52.5%, compared to around 23.3% in the placebo group. The reported data also shows changes in an overall eczema severity score (called SCORAD, ranging 0–103): the dupilumab group showed an average decrease of about 37.8 points, compared to about 20.6 points in the placebo group. For the other reported measures, the dupilumab group showed an average reduction of 4.85 points in a sleep-loss rating (on a 0–10 scale), compared to 2.31 points in the placebo group. On a standardised sleep impairment questionnaire (where lower scores mean less impairment), the dupilumab group's score fell by an average of 11.42 points, compared to 7.77 points in the placebo group. Finally, for total nightly sleep time, the dupilumab group reported sleeping on average 9 minutes more per night by week 12, while the placebo group reported sleeping about 6.4 minutes less. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02816255 · results posted 28 September 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02816255) involved 11 people in total, split into two small groups. Six participants used a full face mask with their existing CPAP (a breathing machine used during sleep) pressure unchanged, while five participants used a full face mask with a newly calculated pressure setting. The trial was measuring changes in sleep apnoea severity, specifically using something called the Apnoea-Hypopnoea Index (AHI) — a count of how many times per hour a person's breathing pauses or becomes very shallow during sleep. The reported data shows that the group using the same CPAP pressure had an AHI score of 2.81 events per hour, while the group using the new pressure setting had an AHI score of 1.59 events per hour. These are the figures as submitted; the trial did not report whether this difference was considered meaningful in a statistical sense. It is also worth noting that both groups were very small, with only five or six people each. The reported data shows that a second outcome — the lowest blood oxygen level reached during sleep — was listed as a planned measurement, but no figures for this outcome were included in the submitted results, so that data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03789214 · results posted 8 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03789214) looked at a sleep medication called suvorexant in people going through opioid withdrawal managed with a medicine called buprenorphine. A total of 38 people started the trial — 12 in the placebo (dummy pill) group, 14 in the low-dose suvorexant group, and 12 in the high-dose suvorexant group. Of those, 26 completed the study (8, 9, and 9 people respectively). The trial was measuring three main things: whether suvorexant produced any feelings of being "high" (which researchers use as a way to assess potential for misuse), how much sleep participants got, and how strongly participants felt withdrawal symptoms. The reported data shows the following numbers across the three groups. For feelings of being "high" (scored on a 0–100 scale, where 0 means none and 100 means extreme), the cumulative scores over the study period were 23.9 for the placebo group, 20.9 for the low-dose group, and 22.8 for the high-dose group. For total sleep time during the buprenorphine taper phase, the cumulative figures were 891.6 minutes×nights for placebo, 1,183.6 for low-dose, and 1,098.4 for high-dose. During the post-taper phase, sleep figures were 1,049.3 for placebo, 1,113.2 for low-dose, and 1,055.9 for high-dose. For self-reported withdrawal symptoms (on a scale of 0–64, where higher means more severe), the cumulative scores during the taper were 15.5 for placebo, 10.8 for low-dose, and 14.8 for high-dose; and during the post-taper phase, 17.9 for placebo, 9.0 for low-dose, and 6.4 for high-dose. Note that the figures for sleep and withdrawal are cumulative totals across multiple nights or days rather than single-night averages, so direct comparisons should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03272763 · results posted 21 June 2022

  According to the results reported on ClinicalTrials.gov, this trial involved 38 participants who all completed the study — none dropped out. The trial was testing a CPAP breathing mask called the F&P Toffee Mask, which is used during sleep therapy for conditions like sleep apnoea. The study looked at how comfortable the mask was, how well it sealed (that is, how much air leaked), how easy it was to use, and whether participants could put it on correctly without help. These were assessed using a mix of questionnaire responses from participants and data recorded directly from their breathing devices. The reported data shows the results as counts of participants falling into different response categories, though the labels for each category were not included in the structured data submitted to ClinicalTrials.gov, so the exact meaning of each number cannot be fully described here. For the primary measure of comfort, participant responses were spread across five categories, with counts of 7, 13, 3, 12, and 3. For usability — whether participants could put the mask on correctly without help — 17 participants fell into one category, 25 into another, and 1 into a third. For ease-of-use compared to their usual mask, counts across five categories were 7, 14, 13, 3, and 1. For the objective (device-recorded) seal performance, counts across four categories were 9, 3, 9, and 17. The secondary measure of leak data recorded by the device showed counts of 1, 3, 10, and 6 across four categories. Because the category labels were not reported in the structured data, it is not possible to say which numbers represent more or less favourable responses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03375203 · results posted 23 May 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03375203) enrolled 365 adults across five groups to study a medicines's effect on sleep. Participants were randomly assigned to receive either a placebo (a dummy pill with no active ingredient), one of three doses of an investigational medicine called JNJ-42847922 (5 mg, 10 mg, or 20 mg), or zolpidem — an existing sleep medicine used for comparison. The trial ran for 13 nights and used a specialised sleep monitoring technique called polysomnography (PSG), which tracks brain activity and sleep patterns overnight in a clinical setting. Between 71 and 75 people started in each group, and the large majority completed the study. The main thing the trial measured was how long it took participants to fall asleep on the first night — specifically the time from "lights out" to the first recorded moment of sleep, known as sleep onset latency. The reported data shows that at the start of the night, the placebo group's time to fall asleep reduced by around 15 minutes from their baseline (starting) level. For the three JNJ-42847922 groups, the reported reductions were approximately 30 minutes (5 mg), 49 minutes (10 mg), and 48 minutes (20 mg). The zolpidem group showed a reported reduction of around 41 minutes. By night 13, the reported reductions in time to fall asleep were approximately 24 minutes for placebo, 27 minutes for the 5 mg dose, 54 minutes for the 10 mg dose, 41 minutes for the 20 mg dose, and 31 minutes for zolpidem. The reported data shows that secondary measures — including how long participants were awake after first falling asleep, and total time spent asleep over 6- and 8-hour windows — were also tracked on nights 1 and 13. For time spent awake after initially falling asleep, reductions (indicating less wakefulness) ranged from about 15 minutes in the placebo group up to around 45 minutes in the 20 mg group on night 1. For total sleep time over 8 hours on night 1, the reported increases from baseline ranged from roughly 37 minutes in the placebo group to about 81 minutes in both the 10 mg and 20 mg groups, with the zolpidem group reporting an increase of approximately 64 minutes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03077620 · results posted 17 May 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total across four groups. Fourteen people with poor sleep were given a placebo (dummy treatment), fourteen with poor sleep were given a 10 mg dose of a sleep medication called suvorexant, fourteen with poor sleep were given a 20 mg dose of suvorexant, and six people who already slept well formed a comparison group. The trial was measuring levels of a protein called amyloid-beta 42 in the fluid surrounding the brain and spinal cord (called cerebrospinal fluid, or CSF). Amyloid-beta is a substance that researchers are interested in because of its possible connection to brain health. Most participants finished the study, with a small number — one each in the placebo and 10 mg groups, and two in the 20 mg group — not completing it. The reported data shows the following amyloid-beta 42 levels (measured in nanograms per millilitre, a standard unit of concentration) recorded across several time points during the study. In the poor-sleep placebo group, readings ranged from approximately 0.573 to 0.602 ng/ml. In the good-sleep comparison group, readings ranged from approximately 0.520 to 0.623 ng/ml. When looking at the three poor-sleep groups side by side, the reported data shows the placebo group ranged from about 0.573 to 0.600 ng/ml, the 10 mg suvorexant group from about 0.519 to 0.544 ng/ml, and the 20 mg suvorexant group from about 0.648 to 0.679 ng/ml across the measured time points. No additional statistical analysis figures (such as whether these differences were considered meaningful by the researchers) were included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04218279 · results posted 5 April 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04218279) involved two groups of people: one group received Sleep Health Education (316 people started, 211 completed) and another group was placed on a Wait List as a comparison (362 people started, 225 completed). The trial was measuring whether a sleep health education program made a difference to people's sleep quality and fatigue levels over three months, compared to simply waiting without receiving the program. The reported data shows that sleep quality was measured using a tool called the Pittsburgh Sleep Quality Index (PSQI), where a higher score means worse sleep quality. The Sleep Health Education group showed an average change of −0.53 points from their starting score, meaning their scores went down slightly, while the Wait List group showed an average change of −0.08 points — also a very small decrease. For fatigue, measured using the Chalder Fatigue Questionnaire (where a higher score indicates more fatigue), the reported data shows the Sleep Health Education group had an average change of +0.19 points, and the Wait List group had an average change of +0.01 points — both very small movements from their starting scores. It is worth noting that a meaningful number of participants did not complete the trial in both groups (105 in the Sleep Health Education group and 137 in the Wait List group), which the reported data does not explain further. The reported data shows only the average score changes described above; no additional detail about what drove those numbers was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03545191 · results posted 25 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03545191) enrolled 930 adults with insomnia, divided equally into three groups of 310: one group received a 25 mg dose of a medicine called daridorexant, one received a 50 mg dose, and one received a placebo (a dummy pill with no active ingredient). The trial was measuring two main things using specialised overnight sleep monitoring: how long people spent awake after first falling asleep (called "wake after sleep onset"), and how long it took them to fall asleep in the first place ("latency to persistent sleep"). These were measured at one month and three months into the trial. A secondary measure was how much total sleep time participants reported themselves in a sleep diary. The reported data shows the following changes from each group's starting point. For time spent awake after falling asleep, at one month the 25 mg group showed a reduction of about 18 minutes, the 50 mg group about 29 minutes, and the placebo group about 6 minutes. At three months, the reported reductions were roughly 23 minutes, 29 minutes, and 11 minutes respectively. For time taken to fall asleep, at one month the 25 mg group showed a reduction of about 28 minutes, the 50 mg group about 31 minutes, and the placebo group about 20 minutes; at three months these figures were roughly 31, 35, and 23 minutes. Notably, the placebo group also showed reductions in both measures across both time points. For the self-reported total sleep time, the reported data shows increases from baseline at one month of approximately 34 minutes (25 mg group), 44 minutes (50 mg group), and 22 minutes (placebo group). At three months, the reported increases were roughly 48 minutes, 58 minutes, and 38 minutes respectively. Again, all three groups — including the placebo group — reported increases in their self-reported sleep time over the course of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02344108 · results posted 11 February 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 42 participants, all of whom completed the study with none dropping out. The trial was testing a device called the Inspire® Upper Airway Stimulation System, which is an implanted device. The study was measuring adverse events (unwanted or harmful experiences) linked to the device, as well as changes in sleep-breathing measures one year after the device was implanted. The reported data shows that, when it came to adverse events, 7 out of 42 participants experienced a "serious" adverse event — meaning one that led to things like hospitalisation, a life-threatening experience, or significant disability. A further 15 out of 42 participants experienced a "non-serious" adverse event that was considered related or possibly related to the device, surgery, or the research itself. Importantly, zero participants experienced what the study defined as an "unanticipated adverse device effect" — that is, a serious, unexpected event believed to be linked to the device. The reported data also shows changes in sleep-breathing scores at one year. The main measure used was the Apnea-Hypopnea Index (AHI) — a count of how many times per hour a person's breathing paused or became very shallow during sleep. On average, participants had an AHI of 11.0 events per hour at one year after implantation, compared to a reported average change of −12.9 events per hour from their starting point before the device was implanted. Similarly, breathing disruptions specifically caused by airway blockage averaged 10.1 events per hour at one year, reflecting an average change of −12.2 from baseline. Breathing disruptions originating from the nervous system (not blockage-related) averaged 0.87 events per hour at one year, with an average change of −0.71 from baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03318003 · results posted 25 January 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 pregnant women who were divided into two groups: 21 received Auto-PAP therapy (a type of breathing support device used during sleep) and 22 received no therapy. The trial was looking at whether the therapy had any relationship to how babies grew in the womb during the last three months of pregnancy, and whether signs of reduced oxygen supply to the placenta (the organ that nourishes the baby) could be detected after birth. A total of 40 women completed the study — 20 in each group. The reported data shows that for the primary outcome — the number of participants whose baby's growth slowed by 33% or more in the last trimester — the result was the same in both groups: 8 out of 20 participants in the Auto-PAP group and 8 out of 20 in the no-therapy group. For the secondary outcome, a pathologist examined the placentas for signs of reduced oxygen supply. The reported data shows that 1 participant in the Auto-PAP group and 4 participants in the no-therapy group had signs of placental oxygen reduction detected. The data also records 12 participants in the Auto-PAP group and 11 in the no-therapy group under a separate category for this outcome measure, though the specific label for that category was not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01485770 · results posted 6 July 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 33 people in total — 17 in one group and 16 in another. It used a "crossover" design, meaning everyone took both the study drug (ADX-N05) and a dummy pill (placebo) at different times, each for two weeks. The trial was measuring daytime sleepiness in people with narcolepsy, a condition that causes excessive daytime drowsiness. The main thing being measured was how long participants could stay awake during a supervised test called the Maintenance of Wakefulness Test (MWT), which asks people to sit quietly and try to remain awake. The reported data shows that, on the primary measure, participants taking ADX-N05 at 300 mg showed an average increase of 12.7 minutes in how long they could stay awake during the MWT test, compared to an average increase of 0.9 minutes for those on placebo. For the secondary measures, a daytime sleepiness questionnaire (the Epworth Sleepiness Scale, scored from 0 to 24 where lower is less sleepy) showed an average score change of −6.7 points for ADX-N05 300 mg versus −2.4 points for placebo at weeks 2 and 4, and −5.3 points for ADX-N05 150 mg versus −1.2 points for placebo at weeks 1 and 3. On a separate doctor-rated improvement scale, 29 out of 33 participants were rated as at least minimally improved while on ADX-N05 150 mg, compared to 9 out of 33 on placebo; and 25 out of 33 were rated as at least minimally improved on ADX-N05 300 mg, compared to 13 out of 33 on placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02317042 · results posted 8 June 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 25 people in total — 11 in one group and 14 in another. All 25 participants completed the trial. The study compared three different modes of breathing support during sleep: a standard ST mode, an AutoEPAP iVAPS mode, and a Fixed EPAP iVAPS mode. The main thing researchers were measuring was the Apnoea-Hypopnoea Index (AHI) — a count of the number of times per hour a person's breathing paused or became very shallow during sleep — when comparing the two iVAPS modes against each other. The reported data shows that the AHI (breathing interruptions per hour) was 3.87 with the standard ST mode, 3.57 with AutoEPAP iVAPS, and 4.09 with Fixed EPAP iVAPS. For the secondary measurements, the number of times per hour blood oxygen levels dropped noticeably was 5.06 (standard ST), 4.45 (AutoEPAP iVAPS), and 5.70 (Fixed EPAP iVAPS). Average blood oxygen levels across the night were reported as 93.99%, 94.01%, and 94.33% respectively. The time spent with blood oxygen below 90% was approximately 37 minutes for both the standard ST and AutoEPAP iVAPS modes, and about 34 minutes for Fixed EPAP iVAPS. The reported average carbon dioxide level measured through the skin was 45.73, 47.44, and 46.78 mmHg (a unit of pressure used to measure gases in the body) across the three modes. Total sleep time was similar across all three, at roughly 333, 332, and 341 minutes respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02549092 · results posted 3 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02549092) enrolled 89 people with Parkinson's disease — 44 in a group receiving optimised medical treatment (adjusting existing medicines) and 45 in a group receiving LCIG (levodopa-carbidopa intestinal gel, a medication delivered directly into the small intestine via a tube). The trial ran for 26 weeks and was mainly measuring two things: non-movement symptoms of Parkinson's disease using a questionnaire called the NMSS (which covers things like sleep, mood, memory, and bladder function, scored from 0 to 360, where lower is better), and sleep problems using a questionnaire called the PDSS-2 (scored from 0 to 60, where lower is better). By the end of the treatment period, 41 people in the medical treatment group and 38 in the LCIG group had completed it. The reported data shows that, for the main NMSS non-movement symptom score, both groups had lower (improved) scores at 26 weeks compared to the start — the optimised medical treatment group's score changed by an average of −23.83 points, and the LCIG group's score changed by an average of −32.04 points. For the sleep questionnaire (PDSS-2), the optimised medical treatment group's score changed by −8.98 points on average and the LCIG group's by −7.41 points on average. For a clinician's overall impression of change (rated 1–7, where 1 means "very much improved" and 4 means "no change"), the reported average score was 4.9 for the optimised medical treatment group and 2.5 for the LCIG group. For a quality-of-life questionnaire (PDQ-8, scored 0–100, lower is better), average score changes were −1.75 and −5.56 respectively. A measure of how well participants could manage daily activities (part of a standard Parkinson's rating scale) changed by +0.53 in the medical treatment group and −2.26 in the LCIG group. Several individual sub-scores for specific non-movement symptom areas were also reported, with both groups showing varying degrees of change across categories such as mood, sleep, and gastrointestinal symptoms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04029311 · results posted 2 April 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT04029311) enrolled 28 people in total — 15 in one group who used a breathing machine (PAP therapy) combined with their own preferred face mask, and 13 in a second group who used the same breathing machine combined with a custom-fitted mask. Both groups were receiving what the trial called "combination therapy" for sleep apnoea, a condition where breathing repeatedly stops or becomes very shallow during sleep. Of the 28 who started, 25 completed the trial (12 from the preferred-mask group and all 13 from the custom-mask group). The reported data shows results across several measurements. For the main sleep-apnoea measure — the number of breathing interruptions per hour (called the Apnea-Hypopnea Index) — the preferred-mask group recorded 4.1 episodes per hour and the custom-mask group recorded 3.6 episodes per hour. The air pressure needed to keep the airway open averaged 9.6 cmH₂O (a standard pressure unit) in the preferred-mask group and 8.6 cmH₂O in the custom-mask group. Air leaking from the mask was recorded at 15.1 litres per minute for the preferred-mask group and 16.7 litres per minute for the custom-mask group. On average, participants used the device for 6.0 hours per night (preferred mask) and 5.9 hours per night (custom mask). Two questionnaires about daytime sleepiness and daily functioning were also measured: the Epworth Sleepiness Scale (scored 0–24, where higher means sleepier) returned scores of 5.5 and 5.8 for the two groups respectively, and the Functional Outcomes Sleep Questionnaire (scored 5–20, where lower means more impact on daily life) returned scores of 36.3 and 36.2 — noting that these figures appear to fall outside the scale's stated range of 5–20 as described in the submitted data, so readers should be aware the data may reflect a different scoring version than described. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00906958 · results posted 22 March 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 in each group. All 20 participants completed the study, with no drop-outs reported. The trial was comparing two different breathing devices used for sleep apnoea: the Nexus Flow Generator (a modified AutoSet device) and the VPAP Flow Generator 25. It was measuring how well each device controlled breathing disruptions during sleep, as well as how comfortable and satisfying participants found each device to use. The reported data shows that for the main (primary) measures, both devices produced similar results. The number of breathing pauses and partial blockages per hour of sleep — known as the Apnoea-Hypopnoea Index, or AHI — was reported as 1.69 events per hour with the Nexus device and 1.73 events per hour with the VPAP device. The number of times blood oxygen levels dropped per hour was 1.95 with the Nexus device and 1.68 with the VPAP device. For the secondary measures — which asked participants to rate their experience on a scale of 0 to 10 — the reported data shows that breathing comfort was rated 8.0 for the Nexus device and 7.0 for the VPAP device; sleep disturbance caused by the device was rated 9.5 and 8.0 respectively (where a higher score means less disturbance); and how refreshed participants felt in the morning was rated 9.0 for the Nexus device and 8.0 for the VPAP device. It is worth noting that this was a very small study with only 10 people per group, and no further statistical detail was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04191668 · results posted 10 March 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT04191668) enrolled 106 participants, and all 106 completed the study with no drop-outs. The trial was comparing two ways of measuring sleep: a standard in-clinic sleep test called polysomnography (PSG), which is considered the reference standard, and a home-based device called NightOwl. The study looked at how closely the two methods agreed when measuring breathing interruptions during sleep (called the apnea-hypopnea index, or AHI), total sleep time, and how well they agreed when placing people into categories of sleep apnea severity. The reported data shows the following results. For the breathing interruption measure (AHI), the two methods produced a correlation coefficient of 0.909 — a correlation coefficient is a number between 0 and 1 that shows how closely two sets of measurements move together, with 1 being a perfect match. For total sleep time, the reported correlation coefficient was 0.610, indicating a lower degree of agreement between the two methods. When it came to placing participants into sleep apnea severity categories, the reported data shows that both methods agreed on the same category for approximately 68.5% of participants (a ratio of 0.685), meaning they placed people into the same severity group about two-thirds of the time. These figures describe the degree of agreement between the two measurement approaches as observed in this particular group of 106 participants. The reported data shows only how closely the measurements aligned — it does not indicate anything about treatment or what any individual should do based on these findings. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02699463 · results posted 26 January 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02699463) involved two groups of participants — one group used Continuous Positive Airway Pressure (CPAP), a device that delivers steady airflow during sleep, and the other was a control group that did not use CPAP. A total of 115 people started in the CPAP group and 118 in the control group. Of those, 100 in the CPAP group and 109 in the control group completed the trial. The main thing the trial was measuring was change in quality of life, specifically looking at energy levels and feelings of fatigue, using a standard questionnaire called the SF-36. Participants answered this questionnaire at the start of the trial and again after three months. The questionnaire uses a scale from 0 to 100, where a higher score means better energy and vitality. The reported data shows that, on average, the CPAP group's score on this scale increased by 7.5 points over the three months, while the control group's average score showed no change (0 points). No secondary outcome measure results were included in the submitted data, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02782780 · results posted 11 January 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 85 people — 46 in a "monitor only" group (who were observed but received no specific sleep intervention) and 39 in a group that received Cognitive Behavioural Therapy for Insomnia (CBTi), a structured talking-based program aimed at improving sleep habits and thoughts about sleep. The trial was designed for veterans with Gulf War Illness, a condition involving a range of ongoing symptoms including sleep problems, fatigue, pain, and cognitive difficulties. Of those who started, 39 in the monitor group and 32 in the CBTi group completed the study, with 7 people in each group not finishing. The reported data shows the following across the two main measures. For overall Gulf War Illness symptom severity (scored 0–87, where higher means more or worse symptoms), both groups started at 67 at baseline. At 8 weeks, the monitor group's score was reported as 61, while the CBTi group's score was reported as 49; the CBTi group's score at 6 months was reported as 54. For insomnia severity (scored 0–28, where higher means worse insomnia), the monitor group started at 19.0 and remained at 19.0 at 8 weeks, while the CBTi group started at 21.0 and was reported at 10.0 at 8 weeks and 13.0 at 6 months. The reported data also shows figures for fatigue, pain interference, pain severity, and self-reported cognitive difficulties at the same time points, with scores shifting to varying degrees across the two groups — details for each of those measures are included in the full data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03882801 · results posted 19 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03882801) looked at whether a medicine called gefapixant (at a dose of 180 mg) had any effect on sleep apnoea. Sleep apnoea is measured using a score called the Apnea-Hypopnea Index (AHI), which counts the number of breathing interruptions during sleep per hour. The trial used a "crossover" design, meaning participants took both the active medicine and a placebo (a dummy treatment with no active ingredient) at different times, with a washout break in between. A total of 24 people started the trial — 12 in each group — though not all completed every stage. The reported data shows that the primary measure was the ratio of each participant's AHI score during treatment compared to their starting score (a ratio of 1.0 would mean no change). For the placebo group, the reported ratio was 0.86, and for the gefapixant 180 mg group, it was 0.97. In plain terms, both numbers are close to 1, suggesting neither group showed a large shift in their breathing interruption scores, though the trial was not designed to draw broad conclusions given its small size. The reported data also shows that, among the secondary measures, 2 out of the participants recorded at least one adverse event (an unexpected or unwanted change in health) while on placebo, compared to 13 while on gefapixant 180 mg. One participant stopped taking the study drug due to an adverse event while on gefapixant, and none did so while on placebo. These are counts of events as recorded, and the trial did not report further breakdown of what those events were in this data submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03795753 · results posted 18 September 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total — 23 in a group using a device called the F2S Communicator, and 13 in a group using a non-functioning version of the device (meaning it did not actually work, acting as a comparison group). All 36 participants completed the trial with no dropouts recorded. The trial was measuring how well people wearing a breathing mask (BPAP or CPAP) could be understood when speaking — both for single words and for full sentences — with and without the communicator device attached to their mask. The reported data shows that, for single word recognition, the F2S Communicator group had a proportion of 0.61 (meaning roughly 61 out of every 100 words were correctly identified by a listening partner), compared to 0.35 (35 in every 100) for the non-functioning device group. For sentence understanding, the reported proportion was 0.76 for the F2S Communicator group (about 76 in every 100 sentences correctly transcribed) versus 0.33 (33 in every 100) for the comparison group. For a secondary measure looking at comfort with the breathing mask, 11 out of 23 participants in the F2S Communicator group reported that the device significantly improved their comfort, compared to 2 out of 13 in the comparison group. A further secondary measure — the Speech Transmission Index, a technical score rating communication quality from 0 (bad) to 1 (excellent) — was listed as an outcome but no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01500759 · results posted 9 July 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 6,876 adults with chronic heart failure (a condition where the heart doesn't pump as well as it should). Participants were divided into two groups: 3,686 people who did **not** have sleep-disordered breathing (SDB — a term for breathing problems during sleep, such as sleep apnoea), and 3,190 people who **did** have SDB. The trial was primarily measuring how common SDB is among people living with chronic heart failure. The reported data shows that of the 6,876 participants, 3,190 — roughly 46% — were found to have SDB alongside their heart failure. Looking at the characteristics of both groups, the average age was reported as 65 years in the group without SDB and 69 years in the group with SDB. Body mass index (a number based on height and weight) was reported as 28.1 and 28.9 respectively. The reported data also shows that the large majority in both groups were male — 2,754 out of 3,686 in the non-SDB group, and 2,674 out of 3,190 in the SDB group. A measure of how well the heart pumps (called left ventricular ejection fraction, reported as a percentage) was 33.6% in the non-SDB group and 32.8% in the SDB group. Additionally, the number of participants with more severe heart failure symptoms (classified as NYHA Class III or above — meaning significant limitation in day-to-day physical activity) was 2,566 in the non-SDB group and 2,341 in the SDB group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03678311 · results posted 2 July 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom had obstructive sleep apnoea (a condition where breathing repeatedly stops and starts during sleep, with a severity score above 5 on a standard sleep study measure). All 9 participants completed the study — none dropped out. The trial was looking at whether the severity of sleep apnoea is connected to something called the "corrected QT interval" (QTc) — a measurement from a heart tracing (ECG) that reflects the timing of the heart's electrical activity. It also aimed to explore whether treating sleep apnoea with a CPAP machine (a device that keeps the airway open during sleep) over 2–3 months would change that heart measurement. The reported data shows that at the baseline (starting) visit, the average QTc measurement for the group was 453.4 units (measured in the square root of seconds, a standard way of expressing this heart timing figure). For the follow-up visit measurement of QTc, no data was reported on ClinicalTrials.gov. Similarly, for the secondary outcome — looking at any change in QTc after CPAP treatment — no results data was reported. Because key follow-up and treatment outcome figures were not submitted to ClinicalTrials.gov, it is not possible to draw any conclusions about what happened after the baseline measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02491788 · results posted 16 June 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02491788) enrolled 19 participants in total — 8 in the drug group and 11 in the placebo group. All 19 participants completed the study, with no drop-outs reported in either group. The trial was measuring changes in daytime sleep duration for people who work night shifts, comparing those who received the study drug against those who received a placebo (an inactive dummy treatment). The reported data shows that the one primary outcome measured was the change in the average amount of sleep participants got during daytime sleep periods after a night shift, compared to where they started before the study (called "baseline"). In the drug group, the reported average change was an increase of 1.83 hours of sleep per sleep opportunity. In the placebo group, the reported average change was a decrease of 0.33 hours of sleep per sleep opportunity. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov. It is worth noting that this was a small study with fewer than 20 participants across both groups, and the results reported here are simply the numbers as submitted — they do not on their own tell us whether any difference seen was meaningful or due to chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01276860 · results posted 12 June 2020

  According to the results reported on ClinicalTrials.gov, this trial involved a total of 7 children — 5 in the Treatment Group (children with obstructive sleep apnoea, which is a condition where breathing repeatedly stops and starts during sleep) and 2 in the Control Group (children without sleep complaints). The trial was measuring participation in a test called the Psychomotor Vigilance Task (PVT) — a simple, non-invasive test where a child presses a button in response to a sound or flashing light, used to measure alertness and attentiveness. Children in the Treatment Group completed the PVT at three separate sessions (before and after treatment), while children in the Control Group completed it once. The reported data shows that all participants who started the trial also completed it — all 5 children in the Treatment Group and both children in the Control Group finished without dropping out. For the primary outcome, the reported data shows that all 5 participants in the Treatment Group successfully completed the full PVT testing sessions. For the secondary outcome, the reported data shows that both 2 participants in the Control Group also fully completed their PVT session. It is important to note that what was being counted here was simply whether participants finished the testing — the data as reported does not include detailed scores or results from the PVT itself. Because this trial involved only 7 participants in total, it was a very small study, and the reported data is limited in scope. No additional outcome figures beyond completion numbers were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00733343 · results posted 12 May 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,325 participants in total — 666 in the treatment group and 659 in the control group. Of these, 583 and 578 respectively completed the study. The trial was measuring outcomes related to heart failure, specifically looking at rates of death and unplanned hospital admissions or extended hospital stays due to worsening heart failure. The reported data shows the following for the primary outcomes: when counting deaths from any cause combined with unplanned heart-failure-related hospitalisations, 360 participants in the treatment group and 335 in the control group experienced this combined outcome. For deaths from cardiovascular (heart-related) causes combined with heart-failure hospitalisations, the numbers were 345 in the treatment group and 317 in the control group. When looking at deaths from any cause combined with any unplanned hospitalisation, 482 participants in the treatment group and 465 in the control group were counted. The reported data also shows results for secondary outcomes — that is, additional things the trial tracked. Deaths from any cause were recorded in 232 participants in the treatment group and 193 in the control group. Deaths specifically from cardiovascular causes were reported in 199 participants in the treatment group and 158 in the control group. Deaths from non-cardiovascular causes were reported in 33 participants in the treatment group and 35 in the control group. No further detail about the reasons for these differences was included in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01196117 · results posted 1 April 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 18 participants who each went through two back-to-back phases: 14 days using a placebo (an inactive treatment designed to look like real therapy) followed by 14 days using a CPAP machine — a device that delivers a steady stream of air to keep the airway open during sleep. All 18 participants completed both phases. The trial was measuring two main things: levels of a stress hormone called cortisol in saliva (collected by mouth swab around 7am and 11pm on days 0, 1, 7, and 14), and daytime sleepiness using a standard questionnaire called the Epworth Sleepiness Score (ESS), which runs from 0 to 24, where higher numbers mean greater sleepiness. The reported data shows that for the sleepiness score, participants recorded an average of 10.7 during the placebo phase and 8.9 during the CPAP phase. For the salivary cortisol primary outcome, no result numbers were reported in the submitted data for the main comparison, so those figures are not available. The reported data also shows cortisol levels broken down by how much participants used their CPAP machine each night. On the morning of day 0 (before treatment began), those who went on to use CPAP for 3 or more hours per night had an average cortisol level of 12.5 nmol/l, compared with 12.1 nmol/l for those who used it less than 3 hours. That same evening, the readings were 3.2 nmol/l and 1.2 nmol/l respectively. On the morning of day 1, the figures were 7.4 nmol/l (higher users) and 13.6 nmol/l (lower users), and that evening 2.2 nmol/l and 1.8 nmol/l. For reference, the trial notes a healthy adult range of below 4.2 nmol/l for this cortisol test. No cortisol data for days 7 or 14 were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02963597 · results posted 30 March 2020

  According to the results reported on ClinicalTrials.gov, this pilot study enrolled 21 people in total — 10 in Group A and 11 in Group B — and all 21 completed the study with no dropouts. The trial was looking at whether continuous positive airway pressure (CPAP) therapy — a breathing device worn during sleep — had any effect on people hospitalised with a sudden worsening of heart failure who also had severe obstructive sleep apnoea (a condition where breathing repeatedly stops during sleep). Researchers tracked several measurements at the start of the hospital stay and again after 48 hours, including blood pressure in the lungs, walking ability, a blood marker linked to heart stress, blood oxygen levels, length of hospital stay, and heart failure symptom severity. The reported data shows the following figures at the start of the study and again at 48 hours. For pressure in the lung's main artery (measured in mmHg, a unit of pressure): Group A started at 58.6 and moved to 42.8, while Group B started at 62.7 and moved to 57.5. For the six-minute walk test (how far someone can walk in six minutes): Group A went from 202.6 metres to 222.6 metres, and Group B went from 153.6 metres to 161.8 metres. For a blood marker called NT-proBNP, which is associated with heart stress: Group A went from 1,087.6 to 466.5 picograms per millilitre, and Group B went from 1,532.7 to 1,500.2 picograms per millilitre. Blood oxygen levels moved from 72.84 to 80.0 mmHg in Group A, and from 76.7 to 77.9 mmHg in Group B. Heart failure symptom scores (on a scale of 1–4, where higher means more severe) were reported only at one time point: Group A averaged 3.2 and Group B averaged 3.5 — the data for a second time point was not reported. Average hospital stay was reported as 9.2 days for Group A and 13.7 days for Group B. It is important to note that this was described as a small pilot study, meaning it was designed primarily to test whether a larger study would be feasible, not to draw firm conclusions. The reported numbers above simply describe what was measured and recorded during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02967367 · results posted 24 March 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 36 participants who were tracked using wearable sleep-monitoring devices — specifically Jawbone/Withings sleep trackers and a Bodymedia Sensewear armband. Of the 36 who started, 22 completed the study and 14 did not finish. The trial was measuring several aspects of sleep, including how long people spent in bed, how long they actually slept, how efficiently they slept (meaning what proportion of time in bed was spent asleep), and how much time was spent in different stages of sleep — "deep sleep" and "light sleep." The reported data shows the following figures across what appear to be different measurement points or conditions (the data does not specify exactly what each set of numbers corresponds to, so each figure is described as reported). For **time spent in bed**, the reported values were 519, 446, 522, and 524 minutes. For **total sleep time**, the reported values were 344, 358, 407, and 431 minutes. For **sleep efficiency** — the share of time in bed actually spent sleeping — the reported figures were 67%, 80%, 78%, and 84%. For the secondary measures, **deep sleep** (as a share of total sleep time) was reported as 83%, 243%, and 192%, and **light sleep** as a share of total sleep time was reported as 190%, 163%, and 239%. It is worth noting that some of these percentage figures appear unusually high and may reflect how the data was entered or calculated; the data as submitted has been described here without alteration. Because the percentage values for deep and light sleep exceed 100% in several instances, readers should be aware that the reported data as submitted to ClinicalTrials.gov may contain errors or use a measurement method not fully explained in the available results. No further detail about what caused these figures was provided in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03383887 · results posted 5 February 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 11 people in total — five in one group and six in another. It used a "crossover" design, meaning each person received both the study drug (called DAW1033D) and a placebo (a dummy treatment with no active ingredient) at different times, so the same participants appear in both treatment groups. Ten of the 11 people completed the study. The trial was measuring two things: first, how often breathing was interrupted during sleep (called the Apnea Hypopnea Index, or AHI — essentially a count of breathing disruptions per hour); and second, how easily the upper airway tended to collapse during sleep. The reported data shows that for the primary measure — breathing disruptions per hour of sleep — participants recorded an average of 21.6 events per hour during the placebo period, compared with 37.9 events per hour during the DAW1033D period. For the secondary measure — airway collapsibility, reported as a percentage of normal breathing effort — the placebo period showed an average of 74.8%, while the DAW1033D period showed 92.7%. These numbers reflect what was recorded and reported; no further breakdown or additional detail was provided in the submitted data. It is worth noting that this was a very small trial with only 11 participants, so these reported figures represent a limited snapshot. The reported data shows only the raw averages for each period, and no further statistical analysis results were included in the submission to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01485393 · results posted 8 October 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 10 healthy volunteers split into two groups of five. It was a "crossover" study, meaning each person tried both sleep medications — one group received zolpidem (a common sleeping tablet) first and then dexmedetomidine (a sedative medication), while the other group received them in the opposite order. All 10 participants completed the study. The trial was measuring changes in sleep patterns — specifically the time spent in different stages of sleep — and how alert participants were after waking up. The reported data shows that, compared to each person's starting point (baseline), those in the zolpidem-induced sleep group showed an average increase of 33.2 minutes of non-REM sleep, a decrease of 35 minutes of REM sleep, and an increase of 35.8 minutes of a deeper sleep stage called N3. For the dexmedetomidine-induced sleep group, the reported changes in non-REM and REM sleep were zero minutes (no change from baseline), with an increase of 26.8 minutes in N3 sleep. For both groups, the reported change in self-reported sleep quantity (from a questionnaire) was zero minutes. Regarding the alertness test after waking — which counted how many times a person's reaction was slower than 400 milliseconds — the zolpidem group recorded an average of 26 slow responses, while the dexmedetomidine group recorded an average of 12 slow responses. It is worth noting that this was a very small study with only 10 participants, so the reported numbers reflect a limited group of healthy volunteers only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02356575 · results posted 2 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people with insomnia — 80 in an acupuncture group and 80 in a group receiving Cognitive Behavioural Therapy for Insomnia (CBT-I, a structured talking-based approach to sleep problems). All 160 participants completed the study. The trial was measuring changes in insomnia symptoms using two questionnaires: the Insomnia Severity Index (ISI), which runs from 0 to 28 with higher scores meaning more severe sleep difficulties, and the Pittsburgh Sleep Quality Index (PSQI), which runs from 0 to 21 with higher scores meaning poorer sleep quality. The reported data shows that at the start of the trial, both groups had similar ISI scores — around 17.6 for the acupuncture group and 18.5 for the CBT-I group — placing both groups in the range considered to indicate clinically significant insomnia (a score of 15 or above). By 8 weeks, the reported change in ISI score was −8.31 for the acupuncture group and −10.91 for the CBT-I group (a negative number means the score went down, i.e. fewer reported sleep difficulties). By 20 weeks, the reported changes were −8.59 and −11.12 respectively. For the PSQI, starting scores were around 11.8 and 12.1. The reported changes at 8 weeks were −4.39 (acupuncture) and −5.90 (CBT-I), and at 20 weeks were −4.62 (acupuncture) and −5.84 (CBT-I). The reported data shows score reductions in both groups across both questionnaires at both time points. The trial was not designed to test individual outcomes, and no conclusions about why scores changed can be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02849184 · results posted 5 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 82 people in total — 40 received a medicine called suvorexant (a sleep medication) and 42 received a placebo (a dummy treatment with no active ingredient). All 82 participants completed the trial. The study was measuring whether suvorexant had any effect on blood pressure during sleep, compared to the placebo, over a two-week period. Blood pressure was tracked using a device worn around the clock (called ambulatory blood pressure monitoring), and participants also kept a sleep diary. The reported data shows that for the main outcome — the change in blood pressure during sleep (specifically the "systolic" reading, which is the top number in a blood pressure measurement) — both groups saw a small reduction. The suvorexant group's sleep systolic blood pressure dropped by an average of 1.8 mmHg (millimetres of mercury, the standard unit for blood pressure), while the placebo group's dropped by 4.4 mmHg. For the secondary outcomes, the reported data shows that total sleep time increased slightly in both groups (by about 0.51 hours in the suvorexant group and 0.43 hours in the placebo group), and the time it took to fall asleep decreased slightly in both groups. Among participants who reported high satisfaction with their sleep, the suvorexant group showed a reported average nighttime blood pressure drop of 6.1 mmHg, compared to a rise of 3.1 mmHg in the placebo group. A kidney health marker called the urine albumin-to-creatinine ratio (a measure of how much protein leaks into urine, which can signal kidney stress) changed by +1.50% in the suvorexant group and −13.12% in the placebo group, though what these changes mean clinically is not explained in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03105297 · results posted 26 July 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03105297) enrolled 91 participants in total, all placed in a single group. The trial was measuring how a nasal dilator strip (a small adhesive strip applied to the outside of the nose) affected nasal airflow and breathing, particularly during sleep. The study had three phases: a starting (baseline) day, an active period where participants used the strip for about four weeks, and a final two-night phase where nasal resistance during sleep was measured using a mask and flow meter. Of the 91 who started, 70 completed the main active phase, and 55 went on to be treated in the final sleep measurement phase. The reported data shows several measurements taken before and after strip application. On the baseline day, the area of the narrowest part of the nasal passage (within the first 3 cm inside the nostril) measured 1.949 cm² without the strip and 2.535 cm² with it. The volume of that same section was reported as 4.145 cm³ without the strip and 5.043 cm³ with it. Nasal resistance — essentially a measure of how hard it is for air to flow through the nose — was recorded at 4.468 units without the strip and 3.251 units with it during the baseline day. During the final sleep phase, nasal resistance was reported as 2.658 units on one night and 2.202 units on the other, though the data as submitted does not clearly separate "with strip" from "without strip" for these overnight readings. The reported data also shows results from questionnaires completed during the active phase. A sleep quality questionnaire (called the FOSQ, scored out of 120 where higher means better day-to-day functioning) returned a total score of 17.55 — the data does not report a comparison score from before the study began, so a before-and-after comparison is not available from this record. Participants were also asked to rate changes in 12 specific experiences (such as ease of breathing, sleep quality, and feeling refreshed) on a scale from −2 (much worse) to +2 (much improved). The reported scores across those 12 items ranged from 0.3 to 1.4, all sitting on the positive side of the scale, though what these numbers mean for any individual was not further detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01027806 · results posted 3 May 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 64 children in total — 32 who received a medicine called montelukast and 32 who received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether montelukast led to a reduction in something called the Apnea-Hypopnea Index (AHI) — a count of how many times per hour a child's breathing was disrupted during sleep. Most children completed the trial: 28 in the montelukast group and 29 in the placebo group. The reported data shows that, of the children in the montelukast group, 20 out of 28 showed a reduction in their AHI score from before treatment to after treatment, while 8 did not show such a reduction. In the placebo group, the reported data shows almost the opposite pattern: 2 out of 29 children showed a reduction in their AHI score, while 27 did not. These are the numbers as submitted — the trial did not report any additional outcome measures in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01925989 · results posted 1 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01925989) involved 27 people in total — 7 in one insulin group, 8 in another, and 12 healthy participants who acted as a comparison group (control). The trial was looking at how two types of long-acting insulin — insulin peglispro and insulin glargine — affected the way the body burns fuel (fats versus sugars) during sleep and rest, in people with Type 1 diabetes. A measure called the "respiratory quotient" (RQ) was used to track this — it is a ratio calculated from the amount of carbon dioxide the body breathes out compared to the oxygen it takes in. A lower RQ generally indicates the body is burning more fat; a higher RQ indicates more sugar burning. The reported data shows that during sleep, people with Type 1 diabetes on insulin peglispro had a recorded RQ of 0.822, while those on insulin glargine had a recorded RQ of 0.846. The healthy control group's sleep RQ was reported as 0.848. For fat burning specifically (measured in grams per day), the reported figures were 0.892 for the insulin peglispro group, 0.900 for the insulin glargine group, and 0.906 for the healthy control group. The reported data also shows that the resting metabolic rate (the number of calories the body burns at rest) was 1,511 kilocalories per day for those on insulin peglispro and 1,403.6 kilocalories per day for those on insulin glargine. For the number of minutes during which the body appeared to be primarily burning fat overnight, the reported figures were 22 minutes for the insulin peglispro group, 8 minutes for the insulin glargine group, and 4.5 minutes for the healthy control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01350505 · results posted 15 February 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 21 participants, all in a single group exposed to light. Of these, 17 completed the study and 4 did not finish. The trial was measuring how different conditions of light exposure at night affected balance while walking — specifically, how steady people's stride length (the distance covered with each step) was under four different lighting conditions during a 13-minute period at night. The reported data shows that stride length variability — a measure of how consistent each step was — was recorded across four separate lighting conditions. The figures reported were 6.66%, 5.34%, 5.62%, and 5.78% (expressed as a percentage coefficient of variation, which is simply a way of showing how much the stride length varied from step to step). According to the study's own description, higher variability in stride length is associated with a greater risk of falling. The reported data does not include a breakdown of which specific lighting condition corresponded to which number, nor does it include a comparison group or statistical analysis detail in the submitted results. It is worth noting that this trial had only one group and a small number of participants, and the results as submitted describe measurements taken within that single group across different conditions. No data was reported for a separate comparison or control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02797678 · results posted 11 January 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at a device called "PowerSleep," which was designed to play audio tones during sleep. The trial enrolled 62 people in an initial screening phase, of whom 37 moved on to the main part of the study. Those 37 participants were split into two groups of roughly equal size — one group used the active device first (with tones playing) and then switched to a dummy version with no tones, while the other group did it the other way around. Each period lasted five nights, with a break in between. A smaller follow-up group of 9 people also took part in an extension phase. The trial was mainly measuring a type of brain-wave activity during sleep called "slow wave activity" (a pattern associated with deep sleep), and also looked at participants' alertness and memory. The reported data shows that during nights with the active device, the average slow wave activity reading was 1,367.9 units (microvolt²), compared to 1,291.3 units during the sham (dummy) nights. For a separate but related measure — the total accumulated slow wave activity across the night — the active device nights recorded 1,333,663.5 units, while the sham nights recorded a higher figure of 1,462,267.3 units. For alertness, measured by how quickly participants reacted in a standard attention test, the average reaction time was 251.4 milliseconds with the active device and 252.1 milliseconds with the sham. For the memory test, participants recalled an average of 35.5 word pairs after active-device nights, compared to 33.86 word pairs after sham nights. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02878590 · results posted 19 December 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02878590) involved 12 people who used a device called the Bongo at home for sleep apnoea. Sleep apnoea is a condition where a person's breathing repeatedly stops and starts during sleep. The trial was measuring changes in something called the Apnea-Hypopnea Index, or AHI — a score that counts how many times per hour a person's breathing pauses or becomes very shallow during sleep. A higher score means more disrupted breathing. Ten of the 12 participants completed the study, and two did not finish. The reported data shows that, among those who completed the trial, the average AHI score at the start (before using the device) was 15.7 events per hour, and the average AHI score at the end (while using the Bongo device) was 7.1 events per hour. The reported difference between these two points was a change of −8.7 events per hour, meaning the scores were lower when measured with the device in use compared to the starting measurement. No other outcome measures appear to have been reported in the submitted data. It is worth noting that this was a very small study — only 10 people completed it — and the data reflects what was measured in those specific participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02043197 · results posted 17 December 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 300 outpatients who had both a neurological disorder and depression, and were being treated with the antidepressant fluvoxamine (brand name Fevarin®). Of those 300 people, 292 completed the study and 8 did not. The trial looked at what types of neurological conditions these patients had, and also tracked changes in their depression and anxiety scores, as well as an overall rating of how unwell they appeared, over the course of treatment. The reported data shows that, when grouping participants by their neurological diagnosis, approximately 49.2% fell into one category of neurological disorder, 31.8% into a second, 20.1% into a third, and 2.7% into a fourth (the specific disorder groupings were not broken down in the submitted results data). For depression symptoms, the trial used a standard questionnaire called the Hospital Anxiety and Depression Scale (HADS), scored from 0 to 21, where higher numbers indicate greater severity. The reported data shows average score changes of −3 points at one time point and −6 points at another for the depression part of the scale, and −3.4 and −6.5 points at those same time points for the anxiety part. Separately, 88.2% of participants were reported to have shown some change in depression symptoms by day 30, while 2.7% showed no change and 9.1% fell into another category (the labels for these categories were not included in the submitted data). On a clinician-rated scale of overall illness severity (rated 1–7, with higher meaning more severely unwell), the average score change reported was −1 point. The reported data also shows that on the same clinician-rated scale, 38.1% of participants were rated in one change category, 46.9% in a second, 11.2% in a third, 2.4% in a fourth, and smaller proportions (0.3%, 0.3%, and 0.7%) in further categories — however, the labels describing what each category means were not included in the submitted results data, so it is not possible to describe them further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02331992 · results posted 29 October 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people in a single group called the "Positive Airway Pressure Adherence Program." All 34 participants who started the study completed it, with none dropping out. The trial was designed to gather feedback — from both participants and healthcare providers — about the program, rather than to test a medical treatment in a traditional sense. The reported data shows that the main thing being measured (the primary outcome) was how many participants provided feedback through questionnaires about the program. Out of the 34 people enrolled, 26 provided this feedback. The secondary outcome looked at how many healthcare providers also completed feedback questionnaires, and the reported data shows that 2 healthcare providers did so. It is worth noting that the trial was focused on collecting opinions and feedback about the program, rather than measuring things like symptoms or health results. No other outcome numbers beyond these participant counts were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02387476 · results posted 23 March 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02387476) enrolled 47 people with sleep apnea across two groups — 25 started with the FRESCA mask before switching to a standard CPAP mask, and 22 started with the CPAP mask before switching to the FRESCA mask. A total of 36 people completed the trial (19 and 17 in each group respectively). The trial was measuring how the two masks compared on several sleep-related readings taken during overnight sleep studies, including the number of breathing interruption events per hour, how often blood oxygen levels dipped, how often people briefly woke from sleep, how efficiently they slept, and what their blood oxygen levels were during sleep. The reported data shows the following numbers for the two main measurements. For the Apnea-Hypopnea Index — a count of breathing interruption events per hour — readings across the different measurement points ranged from about 1.2 to 3.0 for the FRESCA mask group and from about 2.4 to 4.1 for the CPAP mask group. For the Oxygen Desaturation Index — how often per hour blood oxygen levels dropped — figures ranged from roughly 1.1 to 1.4 for the FRESCA group and from about 1.1 to 1.7 for the CPAP group. For the secondary measurements, the reported data shows sleep efficiency percentages ranging from around 79–87% across both groups and treatment nights, minimum blood oxygen levels ranging from roughly 89–92%, and average blood oxygen levels of approximately 95% in both groups. The number of brief wake-ups per hour (arousal index) ranged from about 17 to 23 in the FRESCA group and from about 19 to 24 in the CPAP group across the reported measurement points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01863563 · results posted 7 March 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01863563) enrolled 100 participants, all of whom completed the study — none dropped out. The trial involved a single group of participants who underwent removal of the adenoids and tonsils (a procedure commonly performed in children). During the surgery, a product called QuikClot — a material designed to help control bleeding — was used in the surgical site. The main thing the researchers were measuring was how long surgeons needed to use a suction electrocautery tool (a device that uses heat to stop bleeding) to control any remaining bleeding after the QuikClot was applied. The reported data shows that cauterisation time was measured across what appears to be three separate parts of the procedure. The reported figures were 155.3 seconds, 60.9 seconds, and 94.5 seconds respectively, all measured in seconds. It is worth noting that the data as submitted does not clearly label which of these three figures corresponds to which specific part of the procedure, so a precise breakdown cannot be provided beyond what was reported. It should also be noted that this trial had no comparison group — there was no separate group of patients treated without QuikClot — so the reported numbers describe only what was observed in the single QuikClot group. No comparative figures were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00607893 · results posted 15 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people in total — 77 in the "sham CPAP" group (a dummy version of the breathing device that did not deliver real treatment) and 76 in the "treatment CPAP" group (the real device). The trial was looking at whether CPAP — a machine that delivers continuous air pressure to keep the airway open during sleep — had any effect on certain markers measured in the blood and urine that are linked to oxidative stress (a type of cell damage), inflammation, and cardiovascular (heart and blood vessel) health. The main things being measured were two substances in the body: F2-isoprostanes (found in urine, used as a marker of oxidative stress) and myeloperoxidase (found in blood, also linked to oxidative stress). Around 71–72 people in each group completed the main 8-week phase of the study. The reported data shows that for the primary (main) outcomes, both groups saw a reduction from their starting levels. For F2-isoprostanes, the sham group showed a change of −0.02 ng/mg and the treatment CPAP group showed a change of −0.08 ng/mg. For myeloperoxidase, the sham group changed by −3.33 pmol/L and the treatment CPAP group by −5.15 pmol/L. These figures represent the average change from each group's starting point, adjusted for where participants began. The reported data for the secondary (additional) outcomes shows similarly small changes across both groups. Morning blood pressure (mean arterial) changed by +0.24 mmHg in the sham group and −2.17 mmHg in the treatment group. Evening blood pressure changed by −0.59 mmHg (sham) and −0.72 mmHg (treatment). A measure of arterial stiffness called pulse wave velocity changed by −0.08 cm/s (sham) and −0.30 cm/s (treatment). A blood marker of inflammation called IL-6 changed by +0.29 pg/mL in the sham group and −0.08 pg/mL in the treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02229487 · results posted 14 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 51 adults split into two groups: 24 "normal sleepers" and 27 "short sleepers" (people who sleep less than a typical amount). All 51 participants completed the study with no drop-outs. The trial was measuring levels of a gut hormone called GLP-1 — a substance the body releases after eating that is involved in blood sugar regulation — in people who had been identified as having prediabetes (blood sugar levels higher than normal but not yet at diabetes level). To trigger GLP-1 release, participants drank a sugary liquid as part of a standard test called an oral glucose tolerance test, and their GLP-1 levels were tracked over time. The reported data shows that the short sleepers had a GLP-1 level of 16.66 pmol/l.h (a unit measuring the amount of the hormone in the blood over time), while the normal sleepers had a GLP-1 level of 18.57 pmol/l.h. These are the figures as submitted by the trial sponsor. No secondary outcome measures were included in the submitted results data. It is also worth noting that the trial report does not include information on whether the difference between these two numbers was considered statistically meaningful (that is, unlikely to be due to chance), so that data was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02552303 · results posted 31 July 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people in total across four groups: one group received a talking therapy for insomnia called CBT for Insomnia (CBTI) combined with a wakefulness-promoting medication called armodafinil (10 people); a second group received CBTI combined with a placebo (a dummy pill with no active ingredient, 10 people); a third group received armodafinil alone (8 people); and a fourth group received placebo alone (11 people). The trial was measuring changes in sleep difficulties over time, primarily using a questionnaire called the Insomnia Severity Index (ISI), which asks people to rate their sleep problems on a scale from 0 to 28, where higher numbers indicate more severe sleep difficulties. The reported data shows the following ISI scores at follow-up for each group: the CBTI plus armodafinil group averaged 13.0 out of 28; the CBTI plus placebo group averaged 17.9 out of 28; the armodafinil-only group averaged 7.7 out of 28; and the placebo-only group averaged 6.0 out of 28. It is important to note that the baseline (starting) scores were not separately reported in the submitted results data, so it is not possible from this information alone to calculate how much each group's scores changed from the beginning of the trial. The reported data also shows that dropout numbers — people who did not complete the trial — were 3, 4, 2, and 1 participants respectively across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02656160 · results posted 7 June 2017

  According to the results reported on ClinicalTrials.gov, this trial involved 13 people in total. It used a "crossover" design, meaning each participant had two study nights — on one night they received a drug called dalfampridine (also known as 4-AP), and on the other night they received a placebo (a dummy treatment with no active ingredient). The order was split between the two groups. The trial was measuring the activity of a muscle in the throat called the genioglossus — a tongue muscle involved in keeping the airway open during sleep — using a technique called EMG (which records electrical signals from muscles). The goal was to see how this muscle's activity during sleep compared to its activity while the person was awake. The reported data shows that, for the primary measurement — genioglossus muscle activity during sleep expressed as a percentage of its activity during wakefulness — the placebo group recorded values of 166% and 245%, while the dalfampridine group recorded values of 136% and 163%. The reported data also includes a secondary measurement looking at how much the genioglossus muscle responded to changes in airway pressure during sleep. Here, the placebo group recorded a value of −0.23 %max/cmH2O and the dalfampridine group recorded −0.36 %max/cmH2O. These figures reflect changes in muscle activity relative to pressure changes in the airway. It is worth noting that the number of participants who completed the second study night appears to have dropped from 13 to 10, though no explanation for this was reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02577445 · results posted 6 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total who had been diagnosed with central sleep apnoea (a condition where breathing repeatedly stops during sleep due to signals from the brain). Seventeen of these participants received an implanted device called the remedē System, while 14 did not receive the implant and were followed as a comparison group. The trial was originally planned to run for up to five years, but it was ended early — and as a result, monitored data was only available for up to 24 months for one patient. The reported data shows that, among the 17 participants who received the implanted device, the primary outcome tracked a number of specific events: 6 participants experienced what were recorded as "all-cause" events (meaning any reason), there were 0 deaths reported, 3 participants had serious adverse events (that is, significant medical incidents considered important enough to record formally), 1 participant had a stimulation-related complaint, and 6 participants had device- or cardiovascular-related events. For the 14 participants who did not receive the implant, the reported data shows 0 deaths and 0 hospitalisations recorded up to two years. The reported data shows that no figures were provided for several of the secondary outcomes — including changes in sleep study results, quality of life questionnaires, or heart function measurements — meaning those results were not reported in the data submitted to ClinicalTrials.gov. The trial's early termination appears to have affected how much data was ultimately collected and reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00371293 · results posted 5 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 181 people across three groups: 58 received CPAP therapy (a breathing device used during sleep), 61 followed a weight loss programme, and 62 received a combination of both. After 24 weeks, 136 people completed the study — 48 in the CPAP group, 42 in the weight loss group, and 46 in the combination group. The trial was measuring whether these approaches had any effect on inflammation in the body (using a marker in the blood called CRP), as well as changes in insulin resistance (how well the body manages blood sugar), and blood fat levels including LDL cholesterol, HDL cholesterol, and triglycerides. The reported data shows the following changes from the start of the study to week 24, among participants who stuck to their assigned treatment. For the main measure — inflammation (CRP) — the CPAP-only group showed an 11.47% reduction, the weight loss group showed a 37.45% reduction, and the combination group showed a 32.66% reduction. For insulin resistance (where a higher number suggests the body is handling blood sugar more efficiently), the reported changes were small increases of 0.06 in the CPAP group, 0.43 in the weight loss group, and 0.74 in the combination group. For LDL cholesterol (often called "bad" cholesterol), the reported changes were −3.76 mg/dL, −9.25 mg/dL, and −13.54 mg/dL respectively. For triglycerides (another type of fat in the blood), the reported changes were −7.1, −23.2, and −53.0 mg/dL. For HDL cholesterol (often called "good" cholesterol), the reported changes were −0.62, +0.71, and +0.49 mg/dL across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01804036 · results posted 30 March 2017

  According to the results reported on ClinicalTrials.gov, this trial compared two approaches for people with sleep difficulties: a sleeping medication called zolpidem (brand name Ambien) and a mind-body programme called Mind-Body Bridging. A total of 31 people started in the zolpidem group and 41 in the Mind-Body Bridging group. Of those, 18 and 21 people respectively completed the trial. Participants filled out sleep questionnaires and kept sleep diaries, and measurements were taken at the start of the trial, after one week, and again at two months. The reported data shows changes from the starting point (baseline) on three measures. On a sleep problems questionnaire (scored 0–100, where a higher change means greater reported improvement), the zolpidem group showed a change of 15.8 points at one week and 29.38 points at two months, while the Mind-Body Bridging group showed changes of 16.1 and 21.04 points at those same time points. On an insomnia severity questionnaire (scored 0–28, again where a higher change means greater reported improvement), the zolpidem group showed changes of 4.3 and 9.34 points at one week and two months, compared with 4.0 and 6.38 points for the Mind-Body Bridging group. For total sleep time recorded in sleep diaries, the zolpidem group reported changes of 69.6 minutes at one week and 74.14 minutes at two months, while the Mind-Body Bridging group reported changes of 38.3 and 29.9 minutes at those time points. No secondary outcome data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02578186 · results posted 15 March 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people across two groups in a "crossover" design — meaning each participant tried both the active treatment (diphenhydramine hydrochloride, a type of antihistamine commonly found in over-the-counter sleep aids) and a placebo (a dummy treatment with no active ingredient) at different times. Seventeen people started in the group that received the active treatment first, and 18 started with the placebo first. Of those who began the trial, 25 people completed both periods of the study. The main thing being measured was called "latency to persistent sleep" — in plain terms, this means how many minutes it took a person to fall asleep and stay asleep. The reported data shows that, among those who completed both phases, people took an average of 19.1 minutes to reach persistent sleep when taking diphenhydramine hydrochloride, compared with an average of 27.1 minutes when taking the placebo. It is worth noting that only one outcome measure — time to persistent sleep — was included in the results submitted to ClinicalTrials.gov, and no other measures were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01108081 · results posted 10 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 169 people across four groups: one focused on physical activity (46 people), one on diet (42 people), one on general health education (38 people), and one combining physical activity and diet (43 people). Most participants finished the six-month study — 161 out of 169 completed it. The trial was measuring changes in daytime sleepiness and sleep-related quality of life over those six months, in what appears to be a population experiencing sleep difficulties. The reported data shows that daytime sleepiness was measured using the Epworth Sleepiness Scale, a questionnaire scored from 0 to 24 where a higher number means more sleepiness. Over six months, the reported average change in score was −0.23 (a very small decrease) in the physical activity group, −1.05 in the diet group, +0.43 (a small increase) in the health education group, and −2.62 in the combined physical activity and diet group. A decrease in score means participants reported feeling less sleepy on average, while an increase means slightly more sleepiness was reported — but these are group averages and do not tell us about any individual's experience. The reported data also shows a secondary measure: sleep-related quality of life, scored on a scale of 5 to 20 where higher numbers indicate better quality of life. The average change from the start of the trial to six months was +0.24 in the physical activity group, +0.15 in the diet group, −0.33 in the health education group, and +1.24 in the combined group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01611779 · results posted 6 January 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01611779) involved 5 participants, all of whom received a tongue suspension procedure — a surgical approach where a small implant is used to hold the tongue in a position intended to keep the airway open during sleep. All 5 participants completed the study. The trial was measuring whether the implant could be successfully placed and the tongue stabilised, as well as tracking any complications and changes in sleep-related measurements over time. The reported data shows that the implant was successfully placed and the tongue stabilised in all 5 participants. Regarding complications, the data includes two figures — 1 and 4 participants — though the breakdown of what each number specifically refers to was not fully detailed in the submitted results. For the secondary measurements, the apnea-hypopnea index (a count of breathing interruptions per hour of sleep, where a higher number means more disruptions) was reported at 24.2 at the start, then 15.9, and 34.6 at other time points. A self-reported sleepiness scale (Epworth, scored 0–24, higher meaning more sleepiness) moved from 12.4 down to 7.7, 7.0, and 6.5 across follow-up points. A snoring scale (0–10, higher meaning worse snoring) went from 5.5 down to 2.6, 1.8, 1.8, and 1.7. A quality-of-sleep questionnaire (FOSQ, scored 0–120, higher meaning better) recorded values of 17.2, 18.2, 18.1, and 17.2 across time points. It is worth noting that with only 5 participants, this was a very small study, and the reported figures reflect only those individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02153489 · results posted 9 November 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 adults in total, split into two groups of 15 (called Sequence A and Sequence B). It was a crossover study, meaning participants in each group took turns receiving the active treatment — a medication called aclidinium — and a placebo (a dummy treatment with no active ingredient) during two separate periods. All 30 participants completed both periods. The trial was mainly measuring changes in lung airflow, specifically using a test called FEV1 (the amount of air a person can forcefully breathe out in one second), tracked over a 24-hour period. It also looked at early-morning and night-time breathing-related symptoms in people with COPD (a chronic lung condition). The reported data shows that, for the main measurement — the average change in airflow over 24 hours from the starting point — the aclidinium group showed a change of +0.0953 units, while the placebo group showed a change of -0.0429 units. For the additional pre-specified measurements, the aclidinium group showed increases from baseline in peak airflow (+0.1605 L/sec), morning airflow before the next dose (+0.1128 L/sec), airflow over the first 12 hours (+0.1394 units), and airflow over hours 12–24 (+0.0513 units); the placebo group showed small decreases or minimal changes across all of these. Regarding the symptom score (rated 0–4, where lower means fewer symptoms), the aclidinium group showed a small decrease from their starting score of -0.07, while the placebo group showed a small increase of +0.09. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01259440 · results posted 4 November 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 23 people in total — 13 in a group that received care via video teleconferencing, and 10 in a group that received usual care. The trial was looking at how consistently participants used their CPAP machine (a breathing device worn during sleep), specifically measuring the average number of hours per night they used it over a two-month period. All 23 participants who started the trial completed it. The reported data shows that the video teleconferencing care group used their CPAP machine for an average of 3.4 hours per night, while the usual care group used theirs for an average of 3.6 hours per night. No secondary outcome measures were included in the structured results data submitted to ClinicalTrials.gov, so no further figures are available to report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02152566 · results posted 17 September 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT02152566) enrolled 6 participants in a single group, who underwent sleep studies (overnight monitoring of breathing and sleep patterns) both without and with a nasal high flow therapy device — a treatment that delivers a gentle stream of air through the nose during sleep. Of the 6 people who started the trial, 3 completed it and 3 did not complete it. The trial was set up to measure how well the nasal high flow therapy stabilised breathing during sleep, using signals recorded during the overnight sleep study. The reported data shows that although a primary outcome measure was pre-specified — looking at breathing patterns recorded during the sleep study — no numerical results were submitted for this outcome measure on ClinicalTrials.gov. In other words, the actual measurements for the primary endpoint were not reported in the structured results data, so it is not possible to describe what the numbers showed. No secondary outcome measure data was reported either. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01816685 · results posted 31 August 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01816685) enrolled 135 people who had recently had surgery — 68 in a group that received CPAP (a breathing support device commonly used during sleep) and 67 who received routine care. The trial was measuring whether participants developed delirium (a state of sudden confusion) on the second day after their operation. A total of 114 people completed the study — 58 in the CPAP group and 56 in the routine care group, with 10 and 11 people respectively not completing it. The reported data shows two different tools were used to assess delirium on day two after surgery. The first was a scoring scale called the DRS-R-98, where higher numbers mean more or worse delirium symptoms (the severity portion goes up to 39, and the full scale up to 46). On the severity portion of this scale, the CPAP group averaged a score of 4.8 and the routine care group averaged 5.1. On the full scale score, the CPAP group averaged 7.8 and the routine care group averaged 8.1. The second tool, called the CAM, simply recorded whether delirium was present or absent — it identified 12 participants in the CPAP group and 9 participants in the routine care group as having delirium. The reported data does not include further detail about whether the differences between the two groups were considered meaningful by the researchers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01234675 · results posted 22 July 2015

  According to the results reported on ClinicalTrials.gov, this trial looked at how milnacipran (a medication) compared to a placebo (a dummy treatment with no active ingredient) in terms of sleep. It used a "crossover" design, meaning participants took one treatment for six weeks and then switched to the other, so each person experienced both. A total of 19 people started the trial — 10 in one group and 9 in the other — and most completed both periods, with 15 finishing the full study. The reported data shows the following numbers for the three main (primary) things being measured. For the number of times people woke up after first falling asleep, the milnacipran period recorded an average of 39.5 wake-ups compared to 34.9 during the placebo period. For sleep efficiency — that is, the share of time in bed actually spent asleep — the milnacipran period recorded 77.1% compared to 83.3% during the placebo period. For the total number of minutes spent awake after first falling asleep, the milnacipran period recorded an average of 76.2 minutes compared to 53.6 minutes during the placebo period. The reported data also shows results for three secondary measures: how long it took to fall asleep (41.6 minutes on milnacipran vs 38.6 minutes on placebo), total sleep time (361.7 minutes on milnacipran vs 386.1 minutes on placebo), and the number of brief sleep disturbances per hour (30.2 on milnacipran vs 31.2 on placebo). No information about whether these differences were statistically meaningful was reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01517750 · results posted 24 June 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total, split across four groups based on whether they used an automatic airway pressure (APAP) breathing machine with or without added heated humidification, and whether they were considered at low or high risk of nose and throat complaints (referred to as "nasopharyngeal complaints"). Of the 80 who started, 72 completed the study. The trial was measuring how long per night people used their breathing machine, as well as self-reported daytime sleepiness, impact on daily activities, and nose and throat discomfort. The reported data shows that average nightly device use (the primary measure) ranged from about 281 to 330 minutes per night depending on the group. The group using humidification with a high risk of nose and throat complaints reported 330 minutes, the low-risk humidification group also reported 330 minutes, the low-risk group without humidification reported 321 minutes, and the high-risk group without humidification reported the lowest figure at 281 minutes. For daytime sleepiness (scored out of 24, where above 9 suggests abnormal sleepiness), scores ranged from 4.9 to 9.1 across the groups — the high-risk group without humidification scored 9.1, while all other groups scored below 6. For daily activities (scored up to 100, where higher means less impact on everyday life), scores ranged from 82.0 to 91.7. For nose and throat discomfort (scored out of 25, where higher means more complaints), the reported scores ranged from 4.4 to 10.7, with the high-risk group without humidification reporting the highest score of 10.7. The reported data also includes additional analyses looking at participants who had previously had ear, nose and throat surgery, though these were conducted after the main study plan was set. Device use in those subgroups ranged from approximately 286 to 332 minutes per night. These figures are as submitted by the trial sponsor and no information about whether differences between groups were meaningful was included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01045122 · results posted 27 April 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 11 participants in total. It used a "crossover" design, meaning each person tried both medications — propofol and dexmedetomidine — at different times, so each participant served as their own comparison. The trial was measuring something called the Respiratory Disturbance Index, which counts the number of breathing interruptions or reductions (known as apnoeas and hypopnoeas) that occur per hour during sleep or sedation. This gives a picture of how breathing patterns differed depending on which medication was used. The reported data shows that, on average, participants recorded approximately 57.5 breathing disturbance events per hour while receiving propofol, compared to approximately 21.3 breathing disturbance events per hour while receiving dexmedetomidine. These are the numbers as submitted by the trial's sponsor. No secondary outcome measure data appears to have been reported in the structured results provided to ClinicalTrials.gov. It is worth noting that this was a very small trial with only 11 participants, so these figures reflect a limited snapshot. The reported data shows only what was measured in this specific group under specific conditions — it does not tell us what these numbers would mean for any other person or situation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00333619 · results posted 6 April 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 219 people (110 in a non-drug sleep intervention group and 109 in an active control group). The trial was measuring sleep quality in two ways: first, using a questionnaire called the Pittsburgh Sleep Quality Index (PSQI), where a higher score out of 21 points indicates poorer sleep quality, with scores above 8 suggesting poor sleep; and second, by tracking how much of the time spent in bed participants were actually asleep (called sleep efficiency), measured using a wrist-worn movement monitor over seven nights. The reported data shows that, at the end of the study, the non-drug sleep intervention group had an average PSQI score of 8.6, while the active control group had an average score of 9.4 — both sitting around the threshold that the questionnaire uses to indicate poor sleep quality. For sleep efficiency, the reported data shows the intervention group spent an average of 77.3% of their time in bed asleep, compared to 71.0% for the active control group. It is worth noting that 89 people in the intervention group and 99 in the control group completed the full study, meaning some participants did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02109731 · results posted 25 March 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 15 participants, all of whom completed the study — none dropped out. The trial was looking at a treatment called Negative Airway Pressure (NAP) Delivery, and it was measuring changes in something called the Apnea Hypopnea Index, or AHI. The AHI is a count of how many times per hour a person's breathing is disrupted during sleep (including complete pauses in breathing called apneas, and partial reductions called hypopneas). Participants had their AHI measured before starting the NAP treatment and again after three months of using it, using an overnight sleep study in a laboratory. The reported data shows that the difference between participants' AHI scores before and after the three months of treatment — that is, the change in the number of breathing disruptions per hour — was reported as 4.27 events per hour. This is the only outcome measure included in the submitted results. No other outcome data, such as secondary measures or details about individual participants' before-and-after scores, was reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00393913 · results posted 19 January 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 144 participants who had been diagnosed with sleep apnea. The study was looking at how a treatment called CPAP (Continuous Positive Airway Pressure — a machine that delivers a steady stream of air through a mask while sleeping) affected daytime sleepiness and alertness. Of the 144 people who started the initial assessment, 107 completed it, and 100 went on to the CPAP treatment phase, with 93 finishing that stage. A smaller group of 42 participants then went through a CPAP withdrawal phase, meaning CPAP was temporarily stopped to see what happened. The reported data shows three things were measured across the different stages of the trial. First, **self-reported sleepiness** was measured using a standard questionnaire called the Epworth Sleepiness Scale (a score of 0–24, where higher means sleepier, and above 10 may suggest excessive sleepiness). The three recorded scores across the trial stages were 11.8, 10.2, and 9.9. Second, **how quickly participants fell asleep** during a daytime test (shorter time means sleepier) was recorded as 6.4 minutes, 5.9 minutes, and 7.8 minutes across the stages. Third, **attention and reaction time** was measured by counting "lapses" — moments where a person reacted too slowly to a signal (fewer lapses means better alertness). The reported lapse counts were 5.9, 4.1, and 6.5 across the stages. The data does not specify which exact scores correspond to which phase of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01560975 · results posted 24 November 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study with no dropouts. The trial used a specialised contact lens sensor called the Sensimed Triggerfish to continuously monitor pressure fluctuations inside the eye (known as intraocular pressure, or IOP) over a 24-hour period. The study was looking at how eye pressure patterns changed in people with moderate to severe obstructive sleep apnoea (a condition where breathing repeatedly stops during sleep), both in those who also had a type of glaucoma called primary open-angle glaucoma (POAG) and those who did not. It also looked at whether using a CPAP machine (a device that keeps airways open during sleep) made any difference to those patterns. The reported data shows that the average 24-hour eye pressure fluctuation — measured in units called mVEq/h (a scale used by the Triggerfish device, not a standard pressure unit) — was 44.4 for participants who had glaucoma and used CPAP, and 42.2 for those without glaucoma who used CPAP. For the secondary outcomes, the reported data shows the relationship (called a correlation, meaning how closely two things move together on a scale of 0 to 1) between heart rate and eye pulse rate during sleep: it was 0.36 for the glaucoma/CPAP group, 0.92 for the no-glaucoma/CPAP group, 0.47 for the glaucoma/no-CPAP group, and 0.42 for the no-glaucoma/no-CPAP group. Regarding what happened to eye pressure immediately after the CPAP machine was removed upon waking, the reported figures (in mVEq) were −2.6 for the glaucoma/CPAP group, −25.4 for the no-glaucoma/CPAP group, −40.4 for the glaucoma/no-CPAP group, and −50.3 for the no-glaucoma/no-CPAP group. No further detail about what these changes mean clinically was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01163032 · results posted 16 October 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called tasimelteon in people with a condition called Non-24-Hour Sleep-Wake Disorder — a condition where the body's internal clock does not stay in sync with the normal 24-hour day. The trial had two phases. In the first (randomised) phase, 42 people were assigned to receive tasimelteon and 42 to receive a placebo (a dummy treatment with no active ingredient). In the second, open-label phase (where everyone knew they were receiving tasimelteon), 55 people took part. The trial was mainly measuring whether tasimelteon could help bring participants' body clocks into sync with the 24-hour day — a process called "entrainment" — using urine samples to track the body's natural timing signals. The reported data shows that, for the main measure of entrainment (based on a urine marker called aMT6), 20% of people in the tasimelteon group showed their body clock coming into sync with the 24-hour day, compared with 2.6% in the placebo group. For the second main measure — which combined entrainment with meaningful improvements across several sleep and daily-functioning scores — the reported figures were 23.7% for the tasimelteon group and 0% for the placebo group. A secondary measure also tracked entrainment using a different urine marker (cortisol), with 17.5% in the tasimelteon group and 2.6% in the placebo group meeting that threshold. Another secondary measure used a standard rating scale (scored 1 to 7, where lower numbers suggest more improvement) to capture an overall impression of change; the tasimelteon group averaged a score of 2.6 and the placebo group averaged 3.4 on this scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00548340 · results posted 15 October 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called VEC-162 (tested at two different doses — 20 mg and 50 mg) compared to a placebo (a dummy pill with no active ingredient) in people with sleep difficulties. A total of 322 people started the trial — 109 in the 20 mg group, 109 in the 50 mg group, and 104 in the placebo group. The trial used sleep lab equipment (called PSG, or polysomnography — sensors that record sleep patterns overnight) to measure things like how long it took people to fall into a sustained sleep, how long they spent awake after first falling asleep, and how much total sleep they got. The reported data shows the following changes from each person's starting (baseline) measurements. For the main thing being measured — how many fewer minutes it took to reach 10 consecutive minutes of uninterrupted sleep (averaged across nights 1 and 8) — the 20 mg group showed a reduction of 45.0 minutes, the 50 mg group 46.4 minutes, and the placebo group 28.3 minutes. For time spent awake after first falling asleep, the reductions were 12.2 minutes (20 mg), 14.1 minutes (50 mg), and 11.7 minutes (placebo). For total sleep time gained, the figures were 51.4 minutes (20 mg), 52.0 minutes (50 mg), and 39.9 minutes (placebo). Additional measurements taken later in the trial (nights 22 and 29) showed broadly similar patterns, with reductions in time to fall asleep of 49.4 minutes (20 mg), 45.1 minutes (50 mg), and 33.9 minutes (placebo), though the reported data does not include information on how statistically meaningful these differences between groups were. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00291187 · results posted 15 October 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 412 adults across four groups to study a drug called VEC-162 (tested at three different doses — 20 mg, 50 mg, and 100 mg) compared with a placebo (a dummy treatment with no active ingredient). The main thing being measured was how long it took participants to fall into a sustained sleep after lights went off — a measure called "latency to persistent sleep." A sleep monitoring technique called polysomnography (a test that tracks brain and body activity during sleep) was used to record the results. Almost all participants who started the trial completed it. The reported data shows that, on average, the placebo group took about 45.8 minutes to fall into persistent sleep, while those on VEC-162 took around 24.3 minutes (20 mg group), 19.6 minutes (50 mg group), and 23.1 minutes (100 mg group). For the secondary measure — time spent awake after first falling asleep — the placebo group averaged about 139 minutes awake, compared with roughly 115 minutes (20 mg), 106 minutes (50 mg), and 122 minutes (100 mg) in the VEC-162 groups. Two additional measures were also reported: total sleep time averaged around 318 minutes for placebo versus 351, 366, and 347 minutes across the three VEC-162 doses; and the time to the very first moment of sleep averaged 22 minutes for placebo versus roughly 11, 8, and 10 minutes for the three doses respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00781963 · results posted 2 October 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 159 people in total — 106 in the CBT-I (Cognitive Behavioural Therapy for Insomnia) group and 53 in a control group. Of those, 89 in the CBT-I group and 51 in the control group completed the study. The trial was measuring several aspects of sleep, including how long it took people to fall asleep, how long they were awake during the night, total time awake, the proportion of time in bed actually spent asleep (called "sleep efficiency"), and scores on a standard sleep-quality questionnaire called the Pittsburgh Sleep Quality Index (PSQI), where a score above 8 suggests poor sleep quality. The reported data shows the following end-of-study figures. For time to fall asleep, the CBT-I group averaged 21.3 minutes compared with 31.3 minutes in the control group. For time spent awake after first falling asleep, the CBT-I group averaged 30.3 minutes versus 42.8 minutes in the control group. For total time awake across the whole night, the CBT-I group averaged 73.4 minutes compared with 108 minutes in the control group. Sleep efficiency — the share of time in bed actually spent asleep — was reported as 82.7% for the CBT-I group and 83.1% for the control group, and this figure was the same whether measured by sleep diary or a wrist-worn movement tracker. On the PSQI questionnaire (scored 0–21, with higher meaning poorer sleep), the CBT-I group averaged 6.0 and the control group averaged 7.2. It is worth noting that the sleep efficiency figures were identical across both measurement methods (diary and wrist tracker) for both groups, which may reflect a data-reporting limitation; readers should bear in mind this trial's results describe what was measured at a group level only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01220401 · results posted 8 August 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01220401) involved 21 participants who all received a treatment called ERRT-M. Of those, 18 completed the study and 3 did not. The trial was measuring changes in nightmare frequency, PTSD symptom scores (assessed by a clinician using a structured interview called the Clinician Administered PTSD Scale), and depression scores — tracking these at what appear to be three separate time points across the study. The reported data shows that, for nightmare-related outcomes, the average number of nights per week on which participants experienced nightmares started at 2.61 and was recorded at 0.83 and then 0.97 at the later time points. Similarly, the average number of nightmares per week began at 2.97 and was recorded at 1.17 and then 1.03. For the PTSD symptom interview (scored 0–136, where higher scores reflect more severe symptoms), the reported averages were 50.72, then 46.44, then 43.00 across the three time points. For the depression measure (scored 0–63, where higher scores reflect more depressive symptoms), the reported averages were 27.61, then 18.94, then 22.11. It is worth noting that this was a single-group study with no comparison group, and the participant numbers were small. The reported data shows the average scores recorded at each measurement point, but this study design alone cannot tell us what caused any changes observed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01997723 · results posted 20 June 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01997723) enrolled 75 participants, all of whom completed the study. The trial was looking at whether a portable sleep monitor used at home could measure breathing disruptions during sleep in a similar way to the standard overnight sleep test done in a hospital or sleep laboratory. The key measurement used was called the Apnea Hypopnea Index (AHI) — simply put, this is a count of how many times per hour a person's breathing was disrupted while they slept. The reported data shows three AHI figures recorded for the group: 30.3, 32.3, and 39.1 breathing disruption events per hour. These appear to represent different measurement conditions (such as the home device versus the laboratory test, and possibly a repeat measure), though the data as submitted does not clearly label which figure corresponds to which condition. For the secondary outcome, the reported data shows that the home portable monitor failed to provide usable results in 5.3% of recordings in one measure and 3.1% in another — meaning the vast majority of home tests produced data that could be assessed. A failure was defined as recordings where estimated sleep time was two hours or less, or where less than four hours of usable data was captured. The reported data also shows that 82% of participants indicated they preferred doing the sleep test at home rather than in a laboratory setting. This figure reflects only what participants said they preferred and does not indicate anything about the accuracy or appropriateness of either approach for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01146600 · results posted 12 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total — 13 in one group and 10 in the other. It used a "crossover" design, meaning each person took both the antibiotic clarithromycin and a dummy pill (placebo) at different times, with a rest week in between. Three participants did not finish the first phase, so 20 people completed the full trial. The study was measuring alertness and sleepiness in people who experience ongoing fatigue or excessive sleepiness, using a computer-based reaction-time test (called the Psychomotor Vigilance Task, or PVT), as well as several questionnaires about sleepiness and daily functioning. The reported data shows the following numbers from the main measurement — average reaction time on the computer test at the end of two weeks. During the clarithromycin period, the average reaction time across participants was reported as 279 milliseconds (ms); during the placebo period it was 312 ms; and at the starting point (baseline, before either treatment) it was 334 ms. On the same test at the one-week mark, the reported figures were 285 ms (clarithromycin), 308 ms (placebo), and 334 ms (baseline). For "lapses" — moments where no response was recorded within half a second — the reported averages were 5.7 (clarithromycin), 10.3 (placebo), and 6.5 (baseline). Questionnaire scores were also reported: on the Epworth Sleepiness Scale (0–24, where higher means sleepier), averages were 10.1 (clarithromycin), 14.1 (placebo), and 15.0 (baseline). On the FOSQ quality-of-life scale (5–20, where higher means less impact from sleepiness), scores were 16.6 (clarithromycin), 14.4 (placebo), and 13.9 (baseline). On the SF-36 vitality subscale (0–100, where higher means more energy), scores were 48.9 (clarithromycin), 28.0 (placebo), and 25.0 (baseline). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00642369 · results posted 17 April 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in a group taking quetiapine fumarate and 30 in a group taking haloperidol (both are medicines sometimes used for certain mental health conditions). Of those, 25 people in the quetiapine group and 24 in the haloperidol group completed the trial. The trial was measuring changes in two types of sleep: "slow wave sleep" (a deep, restorative stage of sleep) and "REM sleep" (the dreaming stage), comparing readings at the start of the trial to readings at day 28. The reported data shows the following for **slow wave sleep**: the quetiapine group started at an average of 10.5% and ended at 9.2%, a change of −1.4 percentage points. The haloperidol group started at 8.6% and ended at 6.3%, a change of −2.3 percentage points. For **REM sleep**, the reported data shows the quetiapine group started at 12.6% and ended at 16.4%, a change of +3.9 percentage points. The haloperidol group started at 13.2% and ended at 10.4%, a change of −2.7 percentage points. These numbers represent group averages as recorded in the trial data. It is worth noting that no other outcome measures — such as information about side effects or other aspects of sleep — appear to have been reported in the structured data submitted to ClinicalTrials.gov, so no further figures are available from this source. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01256983 · results posted 28 January 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants in total — 15 in a group that used a light box, and 15 in a group that received no intervention. The trial was measuring **bedtime** (the time at which people went to bed), tracked using a wrist-worn movement monitor called an actimeter over three separate three-week periods. By the end of the study, 14 participants in the light box group and 12 in the no-intervention group had completed the trial. The reported data shows two sets of bedtime figures for each group, expressed in hours using a decimal format (for example, 22.98 hours means approximately 10:59 pm). For the light box group, the reported bedtime values were 7.44 hours and 22.98 hours across the measurement periods. For the no-intervention group, the reported bedtime values were 7.24 hours and 22.48 hours. No further breakdown of the individual measurement time points was provided in the submitted data, and additional context about what these specific numbers represent across the three periods was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01289392 · results posted 12 April 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total — 9 in a Continuous Positive Airway Pressure (CPAP) group, 9 in an Oral Appliance group, and 7 in a Physical Exercise group. All participants who started the trial also completed it, with no drop-outs recorded in any group. The trial was measuring things related to sleep apnoea, including how often breathing disruptions occurred during sleep, as well as broader sleep quality measures and blood markers linked to inflammation. The reported data shows that the primary measure of sleep apnoea — recorded as the average number of breathing disruption events per hour of sleep — was 25.06 for the CPAP group, 30.76 for the Oral Appliance group, and 22.81 for the Physical Exercise group. These numbers reflect what was recorded and reported; the trial does not explain in the submitted data what the participants' event counts were before the interventions began, so it is not possible to describe any before-and-after change from this data alone. For the other primary outcome (detailed sleep stage measurements) and the secondary outcome (inflammation markers from blood samples), the reported data shows no numerical results were submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00608985 · results posted 7 February 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 707 people across four groups to study a sleep medication called almorexant. Participants were randomly assigned to receive either a placebo (a dummy pill with no active ingredient), almorexant at 100 mg, almorexant at 200 mg, or an existing sleep medication called zolpidem at 10 mg. The trial was measuring sleep patterns using both specialised sleep monitoring equipment in a clinic (called polysomnography, which tracks brain activity and sleep stages overnight) and participants' own sleep diaries at home. The main thing being measured was "wake after sleep onset" — that is, how many minutes people spent awake after first falling asleep during the night. The reported data shows that at the start of the trial, all four groups were spending roughly similar amounts of time awake after first falling asleep — around 76 to 92 minutes per night on average, as measured in the clinic. After the first one to two nights of treatment, the reported change from that starting point was: the placebo group woke for about 11.8 minutes less, the almorexant 100 mg group about 29 minutes less, the almorexant 200 mg group about 40.4 minutes less, and the zolpidem group about 17.9 minutes less. By nights 15 and 16, the reported reductions were: placebo 18.3 minutes, almorexant 100 mg about 29.6 minutes, almorexant 200 mg about 36.3 minutes, and zolpidem about 15.1 minutes. For the at-home sleep diary measure over the first two weeks, participants reported reductions of about 14 minutes (placebo), 19.5 minutes (almorexant 100 mg), 21.8 minutes (almorexant 200 mg), and 23.4 minutes (zolpidem). The reported data also shows reductions in the time it took participants to first fall asleep across all groups, with all four groups reporting shorter times to fall asleep compared to their starting point, both in the clinic and in their home diaries. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00642694 · results posted 26 October 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 29 people in total — 14 in a group taking escitalopram (an antidepressant) combined with ramelteon (a sleep medicine), and 15 in a group taking escitalopram combined with a placebo (a dummy pill). The trial was measuring whether adding ramelteon to escitalopram made a difference to depression symptoms and related areas such as sleep, quality of life, and everyday functioning over 12 weeks. Not everyone finished the trial — 8 people completed it in the first group and 11 in the second group. The reported data shows that for the main outcome — the percentage of people whose depression symptoms fell below a set threshold on a clinician-rated scale (called the IDS-C30, where lower scores mean fewer symptoms) — 20% of participants in the escitalopram-plus-ramelteon group reached that threshold at week 12, compared with 36% in the escitalopram-plus-placebo group. For one of the secondary outcomes measuring how many minutes it took participants to fall asleep, the reported average was 30.4 minutes in the ramelteon group and 15.8 minutes in the placebo group. On the quality-of-life and functioning questionnaires (SF-36, Q-LES-Q, SAS-SR, and WSAS), the reported scores were broadly similar between the two groups, with small numerical differences across the various areas measured. It is worth noting that this was a very small trial, and the numbers reported here reflect only the participants who took part in this specific study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00238108 · results posted 25 September 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 16 people in total — 8 in the melatonin group and 8 in the placebo (dummy treatment) group. All 16 participants completed the study, with no drop-outs reported. The trial was measuring sleep quality — specifically how much of an 8-hour sleep opportunity participants actually spent asleep — as well as changes in systolic blood pressure (the "top number" in a blood pressure reading) over a 24-hour period. The reported data shows that, for sleep quality, the melatonin group spent an average of 88.1% of their 8-hour sleep opportunity actually asleep, compared with 80.5% in the placebo group. For the blood pressure measure, the reported data shows a very small average change in systolic blood pressure: the melatonin group had a change of −0.2 mmHg (millimetres of mercury, the standard unit for blood pressure), while the placebo group had a change of −0.4 mmHg. No other outcome figures were reported in the submitted data. It is worth noting that this was a very small study with only 8 people in each group, and the results simply describe what was measured and recorded — they do not on their own tell us whether any difference between the groups is meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01385995 · results posted 26 July 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 50 adults in total — 25 in each group. It was a crossover study, meaning participants tried both treatments at different times: real CPAP (a machine that delivers pressurised air to keep the airway open during sleep) and a sham (fake) CPAP that looked the same but did not provide real airway pressure. There was a one-month "washout" break between the two periods to reduce carry-over effects. The trial was measuring whether CPAP changed blood sugar levels in people who already had impaired glucose tolerance (meaning their blood sugar after a sugary drink was higher than normal but not yet at diabetes levels). The reported data shows that for the main outcome — the number of people whose blood sugar returned to a normal range after a sugary drink test — 7 out of the therapeutic CPAP group and 5 out of the sham CPAP group met that threshold. For the secondary measures, fasting blood sugar averaged 106.4 mg/dL with real CPAP and 105.6 mg/dL with sham CPAP. The two-hour blood sugar reading after the sugary drink averaged 171.1 mg/dL with real CPAP and 178.2 mg/dL with sham CPAP. Fasting insulin levels averaged 16.4 with real CPAP and 17.2 with sham CPAP, while two-hour insulin averaged 110.1 with real CPAP and 114.3 with sham CPAP. A measure of how well the body responds to insulin (called HOMA-IR) was 4.4 with real CPAP and 4.6 with sham CPAP. Finally, an insulin sensitivity score (where a higher number suggests the body is better at using insulin) was reported as 12 for both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01312948 · results posted 19 March 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 6 children who used a breathing mask (called the Pixi paediatric mask) during sleep. All 6 children completed the study. The trial was looking at two main things: how parents rated the usability of the new Pixi mask compared to their child's usual mask, and how often breathing was disrupted during sleep when using each mask. Parents scored each mask on things like how well it sealed to the face, comfort, stability, and whether it left red marks. The reported data shows that parents gave the Pixi mask a usability score of 7.17 out of 10, compared to 5.83 out of 10 for the child's usual mask, on a scale where 0 means poor and 10 means excellent. For the breathing measurement — called the Apnea-Hypopnea Index, or AHI, which counts how many times per hour a child's breathing was disrupted during sleep — the reported data shows a score of 0.85 events per hour with the Pixi mask, compared to 3.25 events per hour with the usual mask. Both of these figures fall below 5, which the researchers noted is the clinical benchmark used in practice. It is worth noting that this was a very small study involving only 6 participants, so the reported numbers reflect a limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00397189 · results posted 28 March 2011

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called Circadin (a slow-release form of melatonin) compared to a placebo (a dummy pill with no active ingredient) in people with sleep difficulties. In the main three-week phase, 394 people were assigned to Circadin and 395 to placebo, with 373 in each group completing that phase. A longer follow-up extension phase also took place, involving 534 people on Circadin and 177 on placebo. The trial's main focus was on measuring how long it took participants to fall asleep, based on their own daily diary records. The reported data shows that, after three weeks, participants in the Circadin group reported that the time it took them to fall asleep changed by an average of minus 19.1 minutes from where they started, while those in the placebo group reported an average change of minus 1.7 minutes. In other words, both groups reported falling asleep faster than at the start, but the reduction recorded in the Circadin group was larger. For the secondary measure — how often people woke up during the night — the Circadin group reported an average change of minus 0.24 wake-ups per night, compared to minus 0.09 for the placebo group, meaning both groups reported slightly fewer night-time wake-ups, with a modestly larger change recorded in the Circadin group. These figures are the averages reported across the groups and reflect what participants recorded in their own sleep diaries; they do not necessarily represent what any individual person might experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00699608 · results posted 12 May 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 91 participants in total across six groups. Each person took all three treatments at different times — eszopiclone (a sleeping tablet), zopiclone (another sleeping tablet), and a placebo (a dummy tablet with no active ingredient) — with a washout break of 4–14 days in between each one. The trial was measuring how well participants could perform coordination and attention tasks the morning after taking each treatment, roughly 7.5 to 11.5 hours after their dose. The main task involved using a slider to keep a cursor lined up with a moving target on a screen, with accuracy measured in pixels (lower pixel scores mean more accurate tracking). The reported data shows that for the main outcome — average tracking error measured between 7.5 and 9.5 hours after the dose — the placebo group scored 10.29 pixels, the eszopiclone group scored 12.49 pixels, and the zopiclone group scored 13.48 pixels. For the secondary tracking measurements taken across a wider range of time points, the reported numbers followed a similar pattern, with placebo scores generally sitting around 9.7–11.0 pixels, eszopiclone around 12.5–13.0 pixels, and zopiclone around 12.9–14.8 pixels. Reaction time scores (lower meaning faster responses) were reported as approximately 747–760 milliseconds for placebo, 787–803 milliseconds for eszopiclone, and 798–811 milliseconds for zopiclone. A separate eye-flicker test (used to assess brain alertness) showed broadly similar scores across all three groups, with only small differences between them across the various time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00519532 · results posted 2 April 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people with Parkinson's disease who received a treatment called rotigotine (delivered as a skin patch). Of the 84 who started, 66 completed the trial and 18 did not finish. The trial was measuring two main things: changes in motor (movement-related) symptoms using a standard Parkinson's rating tool called the UPDRS III, and changes in sleep quality using a Parkinson's-specific sleep questionnaire called the PDSS. Both of these were assessed after 13 weeks of treatment. The reported data shows that, on average, participants' UPDRS III scores — where higher numbers indicate more severe movement problems — changed by minus 5.8 units from the starting point, meaning scores were lower at week 13 than at the beginning. The sleep scale (PDSS) scores also changed by minus 5.8 units on average; on this scale, lower scores indicate fewer sleep-related difficulties. It is worth noting that the two measures used different starting ("baseline") reference points, so they are not directly comparable to each other. The reported data also shows results for two secondary (additional) measures. Scores for nighttime movement difficulties, muscle stiffness, and cramps (measured on a scale of 0–4) changed by an average of minus 1.5 units. The average number of times participants woke during the night to go to the toilet changed by minus 0.4 occasions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00730041 · results posted 9 November 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 51 people in total — 26 received small implants placed in the roof of the mouth (called Pillar® Palatal Implants) and 25 underwent a sham (pretend) procedure with no actual implants. All 26 people in the implant group completed the trial, while 23 of the 25 in the sham group completed it. The trial was looking at whether the implants had any effect on the air pressure settings needed for a CPAP machine — a device worn during sleep to keep the airway open — as well as comfort, satisfaction, sleepiness, and daily functioning. The reported data shows that for the main measurement — the CPAP pressure needed — both groups started at 10.9 centimetres of water and ended at similar levels: 10.3 for the implant group and 9.8 for the sham group. For comfort with CPAP (rated 0–10, where 10 is most comfortable), both groups started around 3.4–3.5 and ended at 5.6 (implant group) and 4.3 (sham group). Satisfaction scores (also 0–10) went from around 3.8–4.2 at the start to 6.5 (implant group) and 5.0 (sham group) at the end. Air leak from the CPAP mask — a measure of how well the mask fitted — was similar across both groups throughout. For daytime sleepiness (scored 0–24, where higher means sleepier), both groups started around 10.7–11.3 and ended at 7.9 (implant group) and 9.7 (sham group). A quality-of-life sleep questionnaire showed scores moving from 15.5 in both groups at the start to 17.4 (implant group) and 16.0 (sham group) at the end. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.