Biomarkers of Insufficient Sleep and Sleepiness

NCT03130803 | Completed DMC

• 1 other identifier: R01HL132150
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation; Insufficient Sleep Syndrome; Sleep Wake Disorders

Outcome Measures

Primary Outcomes (1)

• Plasma Metabolomics Biomarker Fingerprint

  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.

  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 (1)

• Psychomotor Vigilance Test

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

Study Arms (2)

Baseline

NO INTERVENTION

9 hour sleep opportunity at habitual sleep/wake times for 14 days at home and 1 day in lab repeated for visit 1 and visit 2

Insufficient Sleep

EXPERIMENTAL

2 days with 5 hour sleep opportunities immediately following baseline on both visit 1 and visit 2.

Behavioral: Insufficient Sleep

Interventions

Insufficient Sleep BEHAVIORAL

2 days with 5 hour sleep opportunity per day

Insufficient Sleep

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Kenneth P Wright, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 27, 2017
• Study Start: January 19, 2017
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)