Impact of Sleep Restriction on Performance in Adults
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|ClinicalTrials.gov Identifier: NCT02960776|
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : May 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sleep Obesity Sleep Restriction||Behavioral: Sleep Restriction (SR)||Not Applicable|
Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.
This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Long Term Sleep Restriction on Energy Balance|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
No Intervention: Habitual Sleep (HS)
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Experimental: Sleep Restriction (SR)
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase.
Behavioral: Sleep Restriction (SR)
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
- Change in Fat Mass [ Time Frame: Baseline, Week 6 (endpoint) ]Body composition (specifically fat mass) will be measured by MRI at baseline and endpoint.
- Energy Expenditure (EE) [ Time Frame: Weeks 5 and 6 (endpoint) ]EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase.
- Physical activity [ Time Frame: 6 weeks (measured daily) ]Time spent in sedentary, light, moderate, and moderate-to-vigoroud physical activity.
- Appetite-regulating hormones [ Time Frame: Baseline, Week 6 (endpoint) ]Ghrelin, leptin, glucagon-like peptide 1, orexin, NPY
- Neuronal activity [ Time Frame: Week 6 ]Neuronal activity at rest and in response to food stimuli
- NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox) [ Time Frame: Baseline, Week 6 (endpoint) ]Measure cognitive, emotional, sensory, and motor functions, raw scores
- Neuro-behavioral measures [ Time Frame: Baseline, Week 6 (endpoint) ]ModRey memory task
- Immune function [ Time Frame: Baseline, Week 6 (endpoint) ]T-cell stimulation
- Immune markers [ Time Frame: Baseline, Week 6 (endpoint) ]White blood cell populations
- Activity [ Time Frame: Week 5 ]6-minute walk test
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): NCT02960776
|Contact: Marie Pierre St-Onge, PhDemail@example.com|
|Contact: Justin Cochranfirstname.lastname@example.org|
|United States, New York|
|New York Nutrition Obesity Research Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Marie Pierre St-Onge, PhD 212-851-5578 email@example.com|
|Principal Investigator: Marie Pierre St-Onge, PhD|
|Principal Investigator:||Marie Pierre St-Onge, PhD||Columbia University|