Biomarkers of Insufficient Sleep and Sleepiness

University of Colorado Boulder (CU)

Status

Completed

Conditions

Insufficient Sleep Syndrome

Sleep Deprivation

Sleep Wake Disorders

Treatments

Behavioral: Insufficient Sleep

Study type

Interventional

Funder types

Other

Identifiers

NCT03130803

R01HL132150

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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