Biomarkers of Increased Free Living Sleep Time

NCT04214184 | Completed

• 1 other identifier: 133959
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will increase sleep duration in participants who maintain less than 6 hours sleep per night, to target the recommended 7 hours of sleep per night. The focus of this study is determine how increasing nightly sleep duration in these individuals who maintain less than 6 hours sleep per night changes their plasma metabolome and insulin sensitivity. The primary outcome will examine changes in branched-chain amino acids and the secondary outcome will examine changes in insulin sensitivity. The investigators will also determine if changes in plasma metabolites can be used as a biomarker to discriminate between adequate versus insufficient sleep.

Conditions

Sleep Deprivation; Insufficient Sleep Syndrome; Sleep Wake Disorders

Outcome Measures

Primary Outcomes (2)

• Metabolomics-branched chain amino acids change from baseline

  Investigators will measure the abundance of the branched chain amino acids (valine, leucine, isoleucine) in plasma at baseline and at post intervention.

  Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention.

• Insulin Sensitivity change from baseline

  Investigators will measure insulin sensitivity using the oral glucose tolerance test in the morning after overnight sleep assessments in the lab, at baseline and after the four week increased sleep duration intervention.

  Oral glucose tolerance testing will take about 3 hours to complete, and will be tested at baseline and after the four week increased sleep duration intervention.

Secondary Outcomes (1)

• Untargeted Metabolomics change from baseline

  Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention.

Study Arms (1)

Increased Sleep Duration Intervention

EXPERIMENTAL

Following baseline assessments, participants will complete a 4-week increased sleep duration intervention followed by one night of sleep in the lab on this increased sleep duration schedule. In the morning, participants will have blood collected for metabolomics analyses and complete oral glucose tolerance testing

Behavioral: Increased sleep duration

Interventions

Increased sleep duration BEHAVIORAL

Participants will increase their nightly time in bed by 2 hours per night for 4 weeks to target the recommended 7 hours of sleep per night.

Increased Sleep Duration Intervention

Eligibility Criteria

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

You may qualify if:

• years old; men and women
• a. Equal numbers of women and men will be included.
• Body Mass Index (BMI) of \> 18.5 and \<24.9.
• Inactive to habitual moderate physical activity level (\<5 days of exercise per week).
• Sleep/wake history: habitual sleep duration less than 6 hours per night.
• Altitude history: Potential participants must have lived at Denver altitude or higher for at least 3 months.

You may not qualify if:

• Any clinically significant unstable medical or surgical condition within the last year (treated or untreated).
• Any clinically significant psychiatric condition, as defined by DSM-IV-TR. I
• Any clinically significant sleep disorder.
• Use of prescription medications/supplements within one month or need of these medications at any time during the study.
• Symptoms of active illness (e.g., fever).
• Uncorrected visual impairment
• History of shift work in prior year or travel more than one time zone in three weeks prior to study.
• Participants must be entirely drug-free of illicit drugs, medications, nicotine and herbal products for one month prior to study.
• Blood donation in the 30 days prior to inpatient study.
• Ovulating women will be selected on the basis of a history of regular menstrual cycle ranging in length from 25-32 days with a maximum of three days variation month-to-month. They will have no history of prior gynecological pathology, be at least 1 year post-partum, not breast-feeding and not pregnant (HCG pregnancy test at screening and upon admission to the inpatient protocol).

Sponsors & Collaborators

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

Study Sites (1)

Sleep Wake Center--University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Stegman AP, Kubicki M, Mallender Z, Zimmerman GA, Sundar KM, Baron KG, Reisdorph N, Wright KP Jr, Depner CM. From yawn to dawn: the effects of a sleep extension intervention on objective and subjective dimensions of sleep health in adults with habitual short sleep duration. Sleep Adv. 2026 Jan 9;7(1):zpag003. doi: 10.1093/sleepadvances/zpag003. eCollection 2026.

  PMID: 41768370 DERIVED

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

• Christopher Depner

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants with habitual insufficient sleep schedules will complete a 4-week increased sleep duration intervention targeting the recommended 7 hours of sleep per night.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 2, 2020
• Study Start: December 2, 2019
• Primary Completion: September 10, 2024
• Study Completion: December 31, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available upon publication in peer-reviewed journals and will be made available indefinitely.
• Access Criteria: Active membership and username are required to access the raw metabolomics data on Metabolomics Workbench.

Locations

US (1)