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Biomarkers of Insufficient Sleep and Sleepiness

NCT ID: NCT03130803

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2019-02-22

Brief Summary

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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

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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.

Conditions

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Sleep Deprivation Insufficient Sleep Syndrome Sleep Wake Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Baseline

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Insufficient Sleep

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

Group Type EXPERIMENTAL

Insufficient Sleep

Intervention Type BEHAVIORAL

2 days with 5 hour sleep opportunity per day

Interventions

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Insufficient Sleep

2 days with 5 hour sleep opportunity per day

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Wright

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth P Wright, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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Sleep and Chronobiology Laboratory

Boulder, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL132150

Identifier Type: NIH

Identifier Source: org_study_id

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