Clinical trial NCT03130803: Biomarkers of Insufficient Sleep and Sleepiness
Official title: Biomarkers of Insufficient Sleep and Sleepiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Insufficient Sleep Syndrome
Sleep Wake Disorders
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2017-04-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Psychomotor Vigilance Test
timeFrame: Participants will complete the psychomotor vigilance test every 3 hours during scheduled wakefulness across baseline and insufficient sleep for visits one and two
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Sleep and Chronobiology Laboratory
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Kenneth P Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: