Sleep Disorders Trial, Recruiting NCT06694441 Sponsor: Northwestern University Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06694441
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • People aged 55 or older.
  • People who are able to manage their own daily activities independently and who score 26 or higher on a standard memory and thinking test.
  • Women who have been through menopause (this applies because hormonal changes can affect sleep and the body's internal systems being studied).
  • People who spend no more than 8.5 hours in bed each night.
  • People who are not regularly active — meaning they do less than 30 minutes of moderate exercise per day, and exercise fewer than two days per week on a regular basis.
  • People whose daily light exposure is typical of someone who spends most of their time indoors (assessed by questionnaire).

For the insomnia group specifically, people who also meet these criteria may be considered:

  • People whose sleep problems meet the definition of chronic insomnia disorder under an international sleep classification system.
  • People who report sleeping less than 85% of the time they spend in bed, or who regularly wake earlier than wanted (before 6am) on at least 3 nights per week over the past 4 weeks.
  • People who report spending 60 minutes or more awake during the night on at least 3 nights per week over the past 4 weeks (this includes time awake after first falling asleep, as well as time lying awake after waking for the final time).
  • People who score above 5 on a standard sleep quality questionnaire called the PSQI.

For the healthy sleep (control) group specifically, people who also meet these criteria may be considered:

  • People with no history of any type of insomnia disorder.
  • People who report sleeping more than 85% of the time they spend in bed.
  • People who report sleeping an average of between 6.5 and 8 hours per night.
  • People who usually go to bed between 9pm and midnight.
  • People who score 5 or below on the PSQI sleep quality questionnaire.

Who may not be able to join:

  • People who have a sleep disorder other than insomnia, such as restless legs syndrome, sleepwalking or other sleep behaviours, a body clock disorder, or moderate-to-severe sleep apnoea (confirmed by a home sleep test).
  • People who habitually go to bed before 9pm or regularly wake before 5am.
  • People with a history of neurological conditions (conditions affecting the brain or nervous system).
  • People with a history of psychiatric (mental health) conditions.
  • People who score above 19 on a standard depression questionnaire called the BDI-II.
  • People with unstable or serious ongoing medical conditions.
  • People who have been diagnosed with prediabetes or diabetes, or whose blood sugar marker (HbA1c) is 5.7 or higher.
  • People who are currently using, or have used in the past month, medications for sleep, mood, stimulation, or pain relief on more than an occasional basis.
  • People taking certain medications that affect a specific brain signalling system, including beta-blockers, SNRIs, or NDRIs (confirm with trial site if unsure whether a medication applies).
  • People currently using hormone replacement therapy.
  • People taking medications that affect pupil size or how the eyes respond to light, such as antihistamines, anticholinergics, benzodiazepines, or narcotic pain medicines.
  • People with eye conditions that may affect how pupils respond to light, such as significant cataracts, narrow-angle glaucoma, or blindness.
  • People with a history of heart conditions, including irregular heartbeat, coronary artery disease, angina, or heart failure.
  • People who do shift work or who follow an irregular sleep schedule by choice.
  • People with a BMI (a measure of body weight relative to height) above 35.
  • People who regularly smoke six or more cigarettes per week, or consume more than 400mg of caffeine per day.
  • People currently using weight-loss medications.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Daniela Grimaldi, MD, PhD, Northwestern University

Phone: 844-707-5337

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
30 September 2024
Est. completion
31 July 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

24h plasma norepinephrine; Clonidine suppression test; Wake after sleep onset (WASO); Slow oscillatory activity during sleep; Pittsburg Sleep Quality Index; NIH tool box

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov