Impact of Sleep Restriction in Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835261
• Other study ID #: AAAQ7638
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: February 25, 2021

Study information

• Verified date: May 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Obesity
• Sleep

Intervention

Other:
• Sleep Restriction
Mild sleep restriction (-1.5 h/night) over a period of 6 weeks

Locations

Country	Name	City	State
United States	New York Obesity Nutrition Research Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (79)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)	Neuro-behavioral assessments: cognition, motor, sensation raw scores	Weeks 0 and 6
Primary	Change in glucose tolerance	Oral glucose tolerance test	baseline to 6 weeks
Primary	Change in blood pressure	24-hour ambulatory blood pressure; weekly office blood pressure	baseline to 6 weeks
Primary	Flow-mediated dilatation	Endpoint FMD	baseline to 6 weeks
Secondary	Change in Adiposity	Body composition measured by magnetic resonance imaging	baseline to 6 weeks
Secondary	Change in physical activity levels	Time in various behaviors: sedentary, light, moderate, moderate-to-vigorous physical activity	baseline to 6 weeks
Secondary	C-reactive protein	Inflammatory markers	Weeks 0, 3, 4, and 6
Secondary	Interleukin-6	Inflammatory markers	Weeks 0, 3, 4, and 6
Secondary	Tumor necrosis factor	Inflammatory markers	Weeks 0, 3, 4, and 6
Secondary	T cell reactivity to viral loads	Immune markers	Weeks 0 and 6
Secondary	Cholesterol	Total, low-density, and high-density lipoprotein	Weeks 0 and 6
Secondary	Triglycerides	Lipidemia	Weeks 0 and 6
Secondary	Endothelial cell oxidative stress	redox sensitive fluorogenic probe fluorescence intensity	Baseline to 6 weeks
Secondary	Endothelial inflammation	NF-?B nuclear fluorescence area	baseline to 6 weeks