Impact of Sleep Extension in Adolescents (SUNRISE)
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|ClinicalTrials.gov Identifier: NCT03500458|
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : October 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Insulin Sensitivity Sleep Dietary Habits||Behavioral: Sleep Extension||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||December 15, 2022|
|Estimated Study Completion Date :||February 28, 2023|
No Intervention: Typical Sleep
All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.
Experimental: Sleep Extension
Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep.
Behavioral: Sleep Extension
Participants will be asked to increase time in bed at least 1 hour more than baseline
- Change in Insulin Sensitivity [ Time Frame: 2 weeks after Baseline and 7 weeks after Baseline ]Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.
- Change in Sleep Duration & Timing [ Time Frame: At Baseline, 1 week after Baseline, and 6 weeks after Baseline ]Assessed three times with a wrist-worn Actigraphy
- Change in Physical activity [ Time Frame: At Baseline, 1 week after Baseline and 6 weeks after Baseline ]Assessed three times with a triaxial thigh-worn ActivPal
- Change in Dietary Intake [ Time Frame: 1 week after Baseline and 6 weeks after Baseline ]Participants will be asked to complete diet diaries two times for 3 days during each sleep condition (prior to each overnight assessment), listing all food and drink consumed, estimated portion size, and timing of consumption.
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): NCT03500458
|Contact: Stacey Simon, PhDfirstname.lastname@example.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Karissa Valente 720-777-8486 email@example.com|
|Principal Investigator:||Stacey Simon, PhD||Children's Hospital Colorado and University of Colorado Anschutz Medical Campus|