Impact of Sleep Restriction in Women
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|ClinicalTrials.gov Identifier: NCT02835261|
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Cardiovascular Disease Obesity||Other: Sleep Restriction||Not Applicable|
This study will be a randomized, crossover, outpatient sleep restriction (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.
On the first day of each study phase (baseline), participants will come to the research center in the morning after an overnight,12 hour fast. Participants will have anthropometric measurements taken and will then be taken to the department of Radiology to undergo magnetic resonance imaging (MRI) scanning to assess body composition. Flow-mediated dilatation will be performed in the Cardiovascular Ultrasound Laboratory. They will then return to the the clinic for an oral glucose tolerance test. A blood sample will be taken for hormone measurements, and a sample of cells lining the blood vessel (forearm vein) will also be taken to assess endothelial function. Participants will begin the fixed bedtime routine that night. These baseline measurements will be repeated at endpoint, 6 weeks later. Body weight and waist circumference will be measured weekly and fasting blood samples will be taken at week 3 during adherence check visits.
To verify that participants adhere to the sleep protocol, they will be asked to keep a sleep diary and wear an activity monitor 24 hours/day. Participants will wear an actigraph GT3X+ on their wrist, which will serve to track their sleep duration, sleep timing, and physical activity. Two weeks prior to randomization and during the washout period, participants will also wear the actigraph watch and keep a sleep diary to verify sleep duration and sleep-wake schedule. In addition to achieving an average sleep of 7-9 hours/night, by wrist actigraphy, participants will only be enrolled if they achieve 7 hours of sleep for at least 10 of the 14 nights of screening and have <4 nights with <6 hours of sleep. At the time of randomization, a urine pregnancy test and drug screen will be performed. Participants will be asked to abstain from caffeine and alcohol intake for 24 hours prior to the start. Between study phases, if participants have not returned to baseline sleep patterns within the 6 week washout period, an additional 2-4 week washout period will be provided. This washout length will ensure that women are in the same phase of their menstrual cycle at the start of each experimental phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Sleep Restriction on Cardiometabolic Risk Factors in Pre vs Postmenopausal Women|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
No Intervention: Habitual Sleep (HS)
During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule.
Experimental: Sleep Restriction (SR)
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 h in total sleep time. A delay in bedtimes was chosen rather than advancing wakeup time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Other: Sleep Restriction
Mild sleep restriction (-1.5 h/night) over a period of 6 weeks
- Change in glucose tolerance [ Time Frame: baseline to 6 weeks ]Oral glucose tolerance test
- Change in blood pressure [ Time Frame: baseline to 6 weeks ]24-hour ambulatory blood pressure
- Change in Adiposity [ Time Frame: baseline to 6 weeks ]
- Change in physical activity levels [ Time Frame: baseline to 6 weeks ]
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): NCT02835261
|Contact: Marie-Pierre St-Onge, PhDemail@example.com|
|United States, New York|
|New York Obesity Nutrition Research Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Marie-Pierre St-Onge, PhD 212-851-5578 firstname.lastname@example.org|
|Contact: Ayanna Campbell, MS 212-851-5583 email@example.com|
|Principal Investigator: Marie-Pierre St-Onge, PhD|
|Principal Investigator:||Marie-Pierre St-Onge, PhD||Columbia University-New York Obesity Nutrition Research Center|