Biomarkers of Insufficient Sleep and Sleepiness
Completed · Not applicable
Conditions studied: Sleep Deprivation, Insufficient Sleep Syndrome, Sleep Wake Disorders
In brief
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.
Key facts
- Study ID
- NCT03130803
- Run by
- University of Colorado, Boulder
- People needed
- 12
- Starts
- 2017-01-19
- Expected to finish
- 2019-02-22
- Last updated by the study team
- 2020-10-30
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sleep and Chronobiology Laboratory — Boulder, Colorado, United States
Full record on ClinicalTrials.gov
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