RecruitingNot ApplicableNCT04214184

Biomarkers of Increased Free Living Sleep Time

Biomarkers and Altered Metabolic Pathways During Sleep Loss


Sponsor

University of Utah

Enrollment

46 participants

Start Date

Dec 2, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 35 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria10

  • 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).

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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.


Locations(1)

Sleep Wake Center--University of Utah

Salt Lake City, Utah, United States

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NCT04214184


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