Skip to main content
OpenTrials
Completed

NCT Number: NCT03130803

Biomarkers of Insufficient Sleep and Sleepiness

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Deprivation Dyssomnias Insufficient Sleep Syndrome Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insufficient Sleep

Behavioral

2 days with 5 hour sleep opportunity per day

Primary outcomes

  1. Plasma Metabolomics Biomarker Fingerprint

    Time frame: 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

    Investigators can detect ~4,000 plasma metabolites and will identify which metabolites have consistent, sensitive, and specific responses to insufficient sleep across visits one and two. These metabolites will be identified as candidate biomarkers of insufficient sleep.

Secondary outcomes

  1. Psychomotor Vigilance Test

    Time frame: Participants will complete the psychomotor vigilance test every 3 hours during scheduled wakefulness across baseline and insufficient sleep for visits one and two

    The Psychomotor Vigilance Test is a reaction time based test designed to evaluate the ability to sustain attention.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • University of Colorado, Denver

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2017
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.