Biomarkers of Increased Free Living Sleep Time

NCT ID: NCT04214184

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Sleep Deprivation; Insufficient Sleep Syndrome; Sleep Wake Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Increased sleep duration

Intervention Type: 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.

Interventions

Increased 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Christopher Depner

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Depner

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Sleep Wake Center--University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher Depner

Role: CONTACT

Phone: 303-735-1923

Email: christopher.depner@utah.edu

Facility Contacts

Christopher Depner

Role: primary

Other Identifiers

133959

Identifier Type: -

Identifier Source: org_study_id