Trial 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
According to the results reported on ClinicalTrials.gov, this trial (NCT05684523) enrolled 40 people in total — 22 in a placebo group and 18 in the active treatment group (receiving a product called Ze 91019). All 40 participants completed the study. The main purpose of the trial was to test whether the study design itself was practical and workable — in other words, it was primarily checking whether researchers could successfully recruit, enrol, and keep participants engaged over 21 days, including using a Fitbit wearable device, a daily diary, and an online survey. The reported data shows that all participants in both groups completed the study as planned, which was the primary thing being measured. For the secondary measures, sleep was tracked daily over 21 days using a Fitbit. The placebo group averaged about 6.46 hours of sleep per day and spent about 7.40 hours in bed, while the Ze 91019 group averaged about 6.73 hours of sleep per day and spent about 7.72 hours in bed. Two daytime thinking tasks were also measured each day. In a memory task where participants recalled a sequence of digits (out of a possible 12), the placebo group averaged 9.06 correct responses per day and the Ze 91019 group averaged 9.03. In a reaction-time test — where participants pressed a button as quickly as possible when a circle changed colour — the placebo group averaged about 378 milliseconds per response and the Ze 91019 group averaged about 402 milliseconds per response. The reported data shows numbers for both groups across all measures, but this trial was primarily designed to assess whether the study method itself was feasible, not to draw conclusions about whether the treatment produced any particular effect. No safety or efficacy conclusions should be drawn from these figures 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40462685) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Sleep Disorders Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility 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
Who may be able to join
- You are generally healthy
- You can be male or female
- You are between 18 and 65 years old
- You have occasional sleep problems on average 1 to 2 nights per week, with a sleep quality score above 5 on a standard questionnaire, and this has been happening for the past month
- Because of your sleep problems, you experience mental difficulties (such as trouble concentrating or thinking clearly) on at least one day per week on average
- You are fluent in German
- You are willing and able to sign a consent form and follow the study rules
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have been officially diagnosed with insomnia disorder according to standard medical guidelines
- You have a history of a neurological condition (a disorder affecting the brain or nervous system)
- You currently have a psychiatric (mental health) disorder
- You have moderate to severe depression, based on a standard questionnaire score of 15 or higher
- You are currently taking prescribed medications on a regular basis that affect your mood, thinking, or behaviour
- You are currently taking any over-the-counter (non-prescription) products to help with sleep or mood
- You currently live with a chronic pain condition
- You have diabetes
- You have coronary heart disease (a condition affecting the blood supply to the heart)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol
Other options
Data last synced from ClinicalTrials.gov: 17 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.