Biomarkers of Increased Free Living Sleep Time
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|ClinicalTrials.gov Identifier: NCT04214184|
Recruitment Status : Suspended (On hold due to COVID-19 outbreak)
First Posted : January 2, 2020
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Deprivation Insufficient Sleep Syndrome Sleep Wake Disorders||Behavioral: Increased sleep duration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Primary Purpose:||Basic Science|
|Official Title:||Biomarkers and Altered Metabolic Pathways During Sleep Loss|
|Actual Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
Experimental: 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
Behavioral: 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.
- Metabolomics-branched chain amino acids change from baseline [ Time Frame: Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention. ]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 [ 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. ]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.
- Untargeted Metabolomics change from baseline [ Time Frame: Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214184
|United States, Colorado|
|Sleep and Chronobiology Laboratory|
|Boulder, Colorado, United States, 80309|
|Principal Investigator:||Christopher Depner||University of Colorado, Boulder|