Biomarkers of Insufficient Sleep and Sleepiness
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|ClinicalTrials.gov Identifier: NCT03130803|
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Deprivation Insufficient Sleep Syndrome Sleep Wake Disorders||Behavioral: Insufficient Sleep||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Biomarkers of Insufficient Sleep and Sleepiness|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||February 22, 2019|
|Actual Study Completion Date :||February 22, 2019|
No Intervention: Baseline
9 hour sleep opportunity at habitual sleep/wake times for 14 days at home and 1 day in lab repeated for visit 1 and visit 2
Experimental: Insufficient Sleep
2 days with 5 hour sleep opportunities immediately following baseline on both visit 1 and visit 2.
Behavioral: Insufficient Sleep
2 days with 5 hour sleep opportunity per day
- Plasma Metabolomics Biomarker Fingerprint [ Time Frame: Plasma will be collected for metabolomics analyses every 2 hours during scheduled wakefulness at baseline and during the final 24 hours of insufficient sleep for both visits one and two ]Investigators can detect ~4,000 plasma metabolites and will identify which metabolites have consistent, sensitive, and specific responses to insufficient sleep across visits one and two. These metabolites will be identified as candidate biomarkers of insufficient sleep.
- Psychomotor Vigilance Test [ Time Frame: Participants will complete the psychomotor vigilance test every 3 hours during scheduled wakefulness across baseline and insufficient sleep for visits one and two ]The Psychomotor Vigilance Test is a reaction time based test designed to evaluate the ability to sustain attention.
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): NCT03130803
|United States, Colorado|
|Sleep and Chronobiology Laboratory|
|Boulder, Colorado, United States, 80309|
|Principal Investigator:||Kenneth P Wright, PhD||University of Colorado, Boulder|