Impact of Sleep Restriction in Women

May 11, 2022 updated by: Marie-Pierre St-Onge, Columbia University

Impact of Sleep Restriction on Cardiometabolic Risk Factors in Pre vs Postmenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Obesity Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose tolerance
Time Frame: baseline to 6 weeks
Oral glucose tolerance test
baseline to 6 weeks
Change in blood pressure
Time Frame: baseline to 6 weeks
24-hour ambulatory blood pressure; weekly office blood pressure
baseline to 6 weeks
Flow-mediated dilatation
Time Frame: baseline to 6 weeks
Endpoint FMD
baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adiposity
Time Frame: baseline to 6 weeks
Body composition measured by magnetic resonance imaging
baseline to 6 weeks
Change in physical activity levels
Time Frame: baseline to 6 weeks
Time in various behaviors: sedentary, light, moderate, moderate-to-vigorous physical activity
baseline to 6 weeks
C-reactive protein
Time Frame: Weeks 0, 3, 4, and 6
Inflammatory markers
Weeks 0, 3, 4, and 6
Interleukin-6
Time Frame: Weeks 0, 3, 4, and 6
Inflammatory markers
Weeks 0, 3, 4, and 6
Tumor necrosis factor
Time Frame: Weeks 0, 3, 4, and 6
Inflammatory markers
Weeks 0, 3, 4, and 6
T cell reactivity to viral loads
Time Frame: Weeks 0 and 6
Immune markers
Weeks 0 and 6
Cholesterol
Time Frame: Weeks 0 and 6
Total, low-density, and high-density lipoprotein
Weeks 0 and 6
Triglycerides
Time Frame: Weeks 0 and 6
Lipidemia
Weeks 0 and 6
Endothelial cell oxidative stress
Time Frame: Baseline to 6 weeks
redox sensitive fluorogenic probe fluorescence intensity
Baseline to 6 weeks
Endothelial inflammation
Time Frame: baseline to 6 weeks
NF-κB nuclear fluorescence area
baseline to 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weeks 0 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University-New York Obesity Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ7638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with other researchers upon request

IPD Sharing Time Frame

Upon study completion, after publication of main research aims.

IPD Sharing Access Criteria

Contact PI directly

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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