CompletedNot Applicable

Biomarkers of Insufficient Sleep and Sleepiness

United States12 participantsStarted 2017-01-19

Plain-language summary

Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health problems associated with insufficient sleep include inflammation, depression and anxiety, diabetes, stress, drug abuse, poor quality of life, obesity, and fatigue related accidents on the job/while driving. While the contribution of sleep to overall health, well-being, and public safety is recognized, no established clinical biomarkers of sleep deficiency exist. Such biomarkers would have utility as road-side biomarkers of sleepiness (e.g., drowsy driving), monitoring on the job fatigue/fitness for duty (e.g., transportation, military ops health care), monitoring sleep health, as well as for clinical diagnostics and measures of clinical treatment outcomes. Thus, investigators designed a controlled laboratory insufficient sleep protocol utilizing metabolomics to identify biomarkers of insufficient sleep. Investigators propose to identify changes in metabolites that consistently occur during insufficient sleep. As an exploratory outcome investigators will examine associated changes in metabolites and cognitive performance during insufficient sleep.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * normal Body mass index (18.5-24.9) * normal blood chemistries * habitual sleep duration \~7 - 9.25 hours * live at Denver altitude or higher for at least 3 months Exclusion Criteria: * must not be participating in another research study that could influence safe participation in the current study * any clinically significant medical or surgical condition within last year * clinically significant abnormality during physical examination * any physician determined significant abnormality in vital signs, EKG, or clinical laboratory values * any clinically significant psychiatric condition defined by DSM-V * any clinically significant sleep disorder * use of medications/supplements/drugs within one month of study or need of medications during study * symptoms of active illness * uncorrected visual impairment * working shift-work in year prior to study * travel more than 1 time zone in 3 weeks prior to study * pregnant/nursing * greater than moderate caffeine or alcohol use * positive toxicology screening * current smoker

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma Metabolomics Biomarker Fingerprint

Timeframe: Plasma will be collected for metabolomics analyses every 2 hours during scheduled wakefulness at baseline and during the final 24 hours of insufficient sleep for both visits one and two

Trial details

NCT IDNCT03130803

SponsorUniversity of Colorado, Boulder

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-22

View on ClinicalTrials.gov More Sleep Deprivation trials