Biomarkers of Insufficient Sleep and Sleepiness
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 11/17/2018 |
| Start Date: | October 2016 |
| End Date: | July 2019 |
| Contact: | Kenneth P Wright, PhD |
| Email: | kenneth.wright@colorado.edu |
| Phone: | 303-735-1923 |
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.
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.
Impaired sleep affects millions of people each year representing an important public health
issue. This project will utilize metabolomics approaches to identify biomarkers in the blood
that respond consistently to insufficient sleep. The overall goal of this project is to use a
discovery and targeted approach to identify specific small molecules in plasma as candidate
biomarkers of insufficient sleep. Investigators will conduct a controlled in-laboratory
insufficient sleep protocol where participants receive 2 days of 5 hour sleep opportunities
per night on 2 separate occasions. Plasma will be collected for metabolomics analyses every 2
hours (across 24 hours) during scheduled wakefulness at baseline and during insufficient
sleep. Participants will complete the insufficient sleep protocol twice, separated by 23 days
of sufficient sleep, to identify which plasma metabolites consistently change during
insufficient sleep. Investigators anticipate these findings will be the first step in
establishing validated biomarkers of impaired sleep that will advance our understanding,
assessment and management of health consequences and symptoms associated with insufficient
sleep.
issue. This project will utilize metabolomics approaches to identify biomarkers in the blood
that respond consistently to insufficient sleep. The overall goal of this project is to use a
discovery and targeted approach to identify specific small molecules in plasma as candidate
biomarkers of insufficient sleep. Investigators will conduct a controlled in-laboratory
insufficient sleep protocol where participants receive 2 days of 5 hour sleep opportunities
per night on 2 separate occasions. Plasma will be collected for metabolomics analyses every 2
hours (across 24 hours) during scheduled wakefulness at baseline and during insufficient
sleep. Participants will complete the insufficient sleep protocol twice, separated by 23 days
of sufficient sleep, to identify which plasma metabolites consistently change during
insufficient sleep. Investigators anticipate these findings will be the first step in
establishing validated biomarkers of impaired sleep that will advance our understanding,
assessment and management of health consequences and symptoms associated with insufficient
sleep.
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
We found this trial at
1
site
Boulder, Colorado 80309
Principal Investigator: Kenneth P. Wright, PhD
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