Sleep DeprivationNCT04214184
Biomarkers of Increased Free Living Sleep Time
A study testing Increased sleep duration in people with Sleep Deprivation and Insufficient Sleep Syndrome, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Insufficient Sleep Syndrome, Sleep Wake Disorders
- What is being tested?
- Increased sleep duration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old; men and women
- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Wake Center--University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: Biomarkers and Altered Metabolic Pathways During Sleep Loss
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.
- Being tested
- Increased sleep duration
- Medical subject headings
- Sleep Deprivation, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased sleep durationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Increased sleep duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start2 Dec 2019
- Primary completion10 Sep 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants with habitual insufficient sleep schedules will complete a 4-week increased sleep duration intervention targeting the recommended 7 hours of sleep per night.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Principal investigator, Christopher Depner, University of Utah
- Investigators
- Christopher Depner, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214184
- Sponsor's protocol ID
- 133959
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2019
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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