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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
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Marie-Pierre St-Onge, Columbia University

Brief Summary:
The overall goal of this project is to test the hypothesis that long-term, sustained sleep restriction (SR), in women, will lead to increased cardio-metabolic risk. This will be characterized by increases in visceral adiposity, unhealthy lifestyle behaviors (poor dietary quality and low physical activity) and cardio-metabolic risk factors (blood pressure, glucose intolerance) relative to habitual sleep (HS). The investigators expect these changes to be worse in pre- compared to post-menopausal women.

Condition or disease Intervention/treatment Phase
Sleep Cardiovascular Disease Obesity Other: Sleep Restriction Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in glucose tolerance [ Time Frame: baseline to 6 weeks ]
    Oral glucose tolerance test

  2. Change in blood pressure [ Time Frame: baseline to 6 weeks ]
    24-hour ambulatory blood pressure


Secondary Outcome Measures :
  1. Change in Adiposity [ Time Frame: baseline to 6 weeks ]
  2. Change in physical activity levels [ Time Frame: baseline to 6 weeks ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 20-65 years old
  • All racial/ethnic groups
  • Body mass index 25-29.9 kg/m2
  • Sleep 7-9 h in bed/night with no daytime nap
  • Normal scores on:

Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire

Exclusion Criteria:

  • Smokers (any cigarettes or ex-smoker <3 years)
  • Neurological, medical or psychiatric disorder
  • Diabetics
  • Eating and/or sleep disorders
  • Contraindications for MRI scanning
  • Travel across time zones within 4 wk
  • History of drug and alcohol abuse
  • Shift worker (or rotating shift worker)
  • Caffeine intake >300 mg/d
  • Oral contraceptive use or hormone replacement therapy
  • Heavy equipment operators
  • Commercial long-distance drivers.

Information from the National Library of Medicine

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


Contacts
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Contact: Marie-Pierre St-Onge, PhD 212-851-5578 ms2554@cumc.columbia.edu

Locations
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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    ms2554@cumc.columbia.edu   
Contact: Ayanna Campbell, MS    212-851-5583    ac3995@cumc.columbia.edu   
Principal Investigator: Marie-Pierre St-Onge, PhD         
Sponsors and Collaborators
Columbia University
American Heart Association
Investigators
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Principal Investigator: Marie-Pierre St-Onge, PhD Columbia University-New York Obesity Nutrition Research Center

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marie-Pierre St-Onge, Assistant Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT02835261     History of Changes
Other Study ID Numbers: AAAQ7638
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Marie-Pierre St-Onge, Columbia University:
Obesity
Metabolic Disorders
Additional relevant MeSH terms:
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Cardiovascular Diseases