Sleep Disorders Trial, Recruiting NCT02945501 Sponsor: U.S. Army Medical Research and Development Command Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT02945501
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 who are healthy men, or women who are not pregnant and not breastfeeding, between 18 and 39 years old (inclusive)
  • People who are able to show they understand the study rules by scoring at least 80% on a short multiple-choice quiz (one retest is allowed if the first attempt is not passed)

Who may not be able to join:

  • People who typically sleep less than 6 hours or more than 9 hours per night on average
  • People whose usual bedtime on weeknights (Sunday through Thursday) is before 9:00 PM or after 11:00 PM on average
  • People whose usual weekday wake-up time is after 8:00 AM on average
  • People who nap more than once a week as part of their regular routine
  • People whose sleep is regularly unrefreshing, based on scores from a specific sleep quality questionnaire (confirm with trial site)
  • People who typically take more than 20 minutes to fall asleep on average
  • People who consume more than 400 mg of caffeine per day on average (roughly 4 cups of coffee or 8 caffeinated sodas)
  • People whose score on a body-clock preference questionnaire falls outside a specific range, suggesting very strong morning or evening preferences (confirm with trial site)
  • People who score 14 or above on a depression questionnaire
  • People who score 41 or above on an anxiety questionnaire
  • People with a history of heart conditions, including irregular heartbeat, heart valve problems, heart failure, cardiac arrest, or heart attack
  • People with a history of neurological conditions such as epilepsy, seizures, memory loss disorders, hydrocephalus, multiple sclerosis, narcolepsy, or other sleep disorders
  • People with a lung condition that requires daily use of an inhaler
  • People with kidney disease or known kidney problems
  • People with liver disease or known liver problems
  • People with a history of a psychiatric condition that required hospitalisation or psychiatric medication within the last 2 years, or for more than 3 months at any one time
  • People who have smoked or used nicotine products more than once a week within the past year
  • People who drink 14 or more alcoholic drinks per week, or whose alcohol use is considered heavy by the examining study doctor
  • People who use medications or products that cannot be safely stopped during the in-laboratory parts of the study, as determined by the examining study doctor on a case-by-case basis
  • People who currently use illicit drugs, including but not limited to benzodiazepines, amphetamines, cocaine, or marijuana
  • People with a positive pregnancy test result
  • People with a resting blood pressure above 140/90 or a resting heart rate above 110 beats per minute (a repeat measurement within range may allow continued consideration)
  • People with a BMI of 30 or above
  • People with blood or chemistry test results that the study doctor considers clinically significant (repeat testing may be offered)
  • People with a positive urine nicotine or cotinine test at the screening visit
  • People with a positive urine drug test at the screening visit
  • People who have used any sleep aids within the year before screening
  • People who are unable to read and sign the consent form
  • People who do not have access to a quiet, dark sleep environment between 9:00 PM and 7:00 AM for a seven-night period at the start of the study
  • People who are currently taking part in another clinical trial
  • People whose initial screening clearance was more than 90 days before the study session start date (re-screening would be required in that case)

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 19 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: John D. Hughes, CDR, MC, USN, Naval Medical Research Center

Phone: 301-319-9350

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
Sponsor
U.S. Army Medical Research and Development Command
Registry
ClinicalTrials.gov
Start date
27 October 2016
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Point of care safety

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: 19 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