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CompletedNCT04214184Updated Apr 30, 2026

Biomarkers of Increased Free Living Sleep Time

An interventional study of Increased sleep duration in Sleep Deprivation, Insufficient Sleep Syndrome and Sleep Wake Disorders, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by University of Utah · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the detailed description

Impaired sleep affects millions of people each year representing an important public health issue. This project will utilize metabolomics approaches to identify potential mechanisms underlying increased cardiometabolic risk associated with insufficient sleep and to identify potential biomarkers in the blood that respond to insufficient sleep. Investigators will conduct a controlled in-laboratory insufficient protocol where participants will sleep in the lab for one night with sleep timing based on their habitual insufficient sleep schedule. In the morning, plasma will be collected for metabolomics analyses and participants will complete an oral glucose tolerance test for insulin sensitivity analyses. Participants will then complete a 4 -week increased sleep duration intervention targeting the recommended 7 hours of sleep per night. Following this intervention participants will again sleep in the lab for one night on their new sleep schedule. In the morning, plasma will be collected for metabolomics analyses and participants will complete an oral glucose tolerance test for insulin sensitivity analyses. Investigators anticipate these findings will be the first step in developing biomarkers of impaired sleep under free-living sleep conditions, and to determine how such biomarkers relate to insulin sensitivity changes associated with sleep loss.

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Conditions studied

  • Sleep Deprivation
  • Insufficient Sleep Syndrome
  • Sleep Wake Disorders
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In context

Sleep Deprivation

300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.

This study's enrollment of 38 is below the median of 45 across 248 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 18-35 years old; men and women

    a. Equal numbers of women and men will be included.

  2. Body Mass Index (BMI) of > 18.5 and \<24.9.
  3. Inactive to habitual moderate physical activity level (\<5 days of exercise per week).
  4. Sleep/wake history: habitual sleep duration less than 6 hours per night.
  5. Altitude history: Potential participants must have lived at Denver altitude or higher for at least 3 months.

Exclusion criteria

Exclusion Criteria:

  1. Any clinically significant unstable medical or surgical condition within the last year (treated or untreated).
  2. Any clinically significant psychiatric condition, as defined by DSM-IV-TR. I
  3. Any clinically significant sleep disorder.
  4. Use of prescription medications/supplements within one month or need of these medications at any time during the study.
  5. Symptoms of active illness (e.g., fever).
  6. Uncorrected visual impairment
  7. History of shift work in prior year or travel more than one time zone in three weeks prior to study.
  8. Participants must be entirely drug-free of illicit drugs, medications, nicotine and herbal products for one month prior to study.
  9. Blood donation in the 30 days prior to inpatient study.
  10. 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).
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Increased Sleep Duration Intervention

    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

  • BehavioralIncreased sleep duration

    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.

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    Time frame: 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

    Investigators can detect relative abundance of \~4,000 plasma metabolites. A combination of metabolites that can discriminate between adequate versus insufficient sleep will be identified as a potential biomarkers of insufficient sleep in free-living adults.

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

07

Study locations

1 site
  • Sleep Wake Center--University of Utah
    Salt Lake City, Utah 84108, United States
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References and documents

Publications

  • 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. PubMed 41768370 ↗

Individual participant data

Plan to share: Yes — Any data generated from the proposed work that is presented in a peer reviewed journal will be uploaded, de-identified, into the Metabolomics Data Repository and Coordinating Center (DRCC) (U01) through UCSD; http://www.metabolomicsworkbench.org/nihmetabolomics/datasharing.html. In addition, .raw data that is presented in a peer reviewed journal will be archived indefinitely and made available upon request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04214184
Lead sponsor
University of Utah
Collaborators
University of Colorado, Boulder
Responsible party
Christopher Depner (Assistant Professor, University of Utah) — Principal investigator
First posted
Jan 2, 2020
Start date
Dec 2, 2019
Primary completion
Sep 10, 2024
Completion
Dec 31, 2025
Last update
Apr 30, 2026

Study contacts

Christopher Depner
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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