Biomarkers of Increased Free Living Sleep Time
Completed · Not applicable
Conditions studied: Sleep Deprivation, Insufficient Sleep Syndrome, Sleep Wake Disorders
In brief
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.
Key facts
- Study ID
- NCT04214184
- Run by
- University of Utah
- People needed
- 38
- Starts
- 2019-12-02
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18-35 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).
Where it is running
- Sleep Wake Center--University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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