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Biomarkers of Increased Free Living Sleep Time

Primary Purpose

Sleep Deprivation, Insufficient Sleep Syndrome, Sleep Wake Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Increased sleep duration

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

Sleep Wake Center--University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Increased Sleep Duration Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04214184

First Posted

December 17, 2019

Last Updated

June 10, 2023

Sponsor

University of Utah

Collaborators

University of Colorado, Boulder

1. Study Identification

Unique Protocol Identification Number

NCT04214184

Brief Title

Biomarkers of Increased Free Living Sleep Time

Official Title

Biomarkers and Altered Metabolic Pathways During Sleep Loss

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 2, 2019 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

University of Colorado, Boulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation, Insufficient Sleep Syndrome, Sleep Wake Disorders

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Increased Sleep Duration Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Increased sleep duration

Intervention Description

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.

Primary Outcome Measure Information:

Title

Metabolomics-branched chain amino acids change from baseline

Description

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.

Title

Insulin Sensitivity change from baseline

Description

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 Outcome Measure Information:

Title

Untargeted Metabolomics change from baseline

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christopher Depner

Phone

303-735-1923

christopher.depner@utah.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Depner

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sleep Wake Center--University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Depner

Phone

801-581-2275

sleepstudyparticipant@utah.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data will become available upon publication in peer-reviewed journals and will be made available indefinitely.

IPD Sharing Access Criteria

Active membership and username are required to access the raw metabolomics data on Metabolomics Workbench.

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Biomarkers of Increased Free Living Sleep Time

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