We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Sleep Restriction in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02835261
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : May 12, 2022
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 project is funded by the American Heart Association Go Red for Women Strategically Focused Research Network (SFRN). This SFRN includes two separate projects: Clinical Science Project (PI, St-Onge) and Basic Science Project (PI, Jelic). Women are enrolled in the Clinical Science project and given the option to enter the Basic Science project. Each project (clinical and basic) has its own separate primary and secondary outcomes. For the Clinical Science project, primary outcomes are glucose tolerance and ambulatory and office blood pressure; and secondary outcomes are body composition and circulating inflammatory markers. For the Basic Science project, the primary outcomes are flow mediated dilatation of the brachial artery (FMD) and secondary outcomes are endothelial cell oxidative stress and inflammation. The results of these two projects will be reported in separate and in combined publications.

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 followed by endothelial cell harvesting (Basic Science project). A sample of cells lining the blood vessel (forearm vein) will be taken to assess endothelial function. Women will undergo an oral glucose tolerance test (Clinical Science project). Blood samples will be taken for hormone measurements (insulin, cortisol). 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 weeks 3 and 4 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 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 : September 1, 2016
Actual Primary Completion Date : February 25, 2021
Actual Study Completion Date : February 25, 2021

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; weekly office blood pressure

  3. Flow-mediated dilatation [ Time Frame: baseline to 6 weeks ]
    Endpoint FMD


Secondary Outcome Measures :
  1. Change in Adiposity [ Time Frame: baseline to 6 weeks ]
    Body composition measured by magnetic resonance imaging

  2. Change in physical activity levels [ Time Frame: baseline to 6 weeks ]
    Time in various behaviors: sedentary, light, moderate, moderate-to-vigorous physical activity

  3. C-reactive protein [ Time Frame: Weeks 0, 3, 4, and 6 ]
    Inflammatory markers

  4. Interleukin-6 [ Time Frame: Weeks 0, 3, 4, and 6 ]
    Inflammatory markers

  5. Tumor necrosis factor [ Time Frame: Weeks 0, 3, 4, and 6 ]
    Inflammatory markers

  6. T cell reactivity to viral loads [ Time Frame: Weeks 0 and 6 ]
    Immune markers

  7. Cholesterol [ Time Frame: Weeks 0 and 6 ]
    Total, low-density, and high-density lipoprotein

  8. Triglycerides [ Time Frame: Weeks 0 and 6 ]
    Lipidemia

  9. Endothelial cell oxidative stress [ Time Frame: Baseline to 6 weeks ]
    redox sensitive fluorogenic probe fluorescence intensity

  10. Endothelial inflammation [ Time Frame: baseline to 6 weeks ]
    NF-κB nuclear fluorescence area


Other Outcome Measures:
  1. NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox) [ Time Frame: Weeks 0 and 6 ]
    Neuro-behavioral assessments: cognition, motor, sensation raw scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 20-75 years old
  • All racial/ethnic groups
  • Body mass index 18.5-34.9 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
  • Regular use of any medication or supplement
  • 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


Locations
Layout table for location information
United States, New York
New York Obesity Nutrition Research Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
American Heart Association
Investigators
Layout table for investigator information
Principal Investigator: Marie-Pierre St-Onge, PhD Columbia University-New York Obesity Nutrition Research Center
Principal Investigator: Sanja Jelic, MD Columbia University
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Marie-Pierre St-Onge, Assistant Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT02835261    
Other Study ID Numbers: AAAQ7638
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with other researchers upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Upon study completion, after publication of main research aims.
Access Criteria: Contact PI directly
Keywords provided by Marie-Pierre St-Onge, Columbia University:
Obesity
Metabolic Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases