Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-01
Study Completion Date
2021-02-25
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Sleep
Cardiovascular Disease
Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Habitual Sleep (HS)
During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Sleep Restriction
Intervention Type
OTHER
Mild sleep restriction (-1.5 h/night) over a period of 6 weeks
Interventions
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Sleep Restriction
Mild sleep restriction (-1.5 h/night) over a period of 6 weeks
Intervention Type
OTHER
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
20 Years
Maximum Eligible Age
75 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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American Heart Association
OTHER
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
lead
Responsible Party
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Marie-Pierre St-Onge
Assistant Professor of Nutritional Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Marie-Pierre St-Onge, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University-New York Obesity Nutrition Research Center
Sanja Jelic, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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New York Obesity Nutrition Research Center
New York, New York, United States
Site Status
Countries
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United States
References
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Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2.
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Shechter A, Rising R, Wolfe S, Albu JB, St-Onge MP. Postprandial thermogenesis and substrate oxidation are unaffected by sleep restriction. Int J Obes (Lond). 2014 Sep;38(9):1153-8. doi: 10.1038/ijo.2013.239. Epub 2013 Dec 19.
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St-Onge MP, Shechter A, Shlisky J, Tam CS, Gao S, Ravussin E, Butler AA. Fasting plasma adropin concentrations correlate with fat consumption in human females. Obesity (Silver Spring). 2014 Apr;22(4):1056-63. doi: 10.1002/oby.20631. Epub 2013 Oct 17.
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St-Onge MP, Wolfe S, Sy M, Shechter A, Hirsch J. Sleep restriction increases the neuronal response to unhealthy food in normal-weight individuals. Int J Obes (Lond). 2014 Mar;38(3):411-6. doi: 10.1038/ijo.2013.114. Epub 2013 Jun 19.
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Shechter A, O'Keeffe M, Roberts AL, Zammit GK, RoyChoudhury A, St-Onge MP. Alterations in sleep architecture in response to experimental sleep curtailment are associated with signs of positive energy balance. Am J Physiol Regul Integr Comp Physiol. 2012 Nov 1;303(9):R883-9. doi: 10.1152/ajpregu.00222.2012. Epub 2012 Sep 12.
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St-Onge MP, McReynolds A, Trivedi ZB, Roberts AL, Sy M, Hirsch J. Sleep restriction leads to increased activation of brain regions sensitive to food stimuli. Am J Clin Nutr. 2012 Apr;95(4):818-24. doi: 10.3945/ajcn.111.027383. Epub 2012 Feb 22.
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St-Onge MP, Roberts A, Shechter A, Choudhury AR. Fiber and Saturated Fat Are Associated with Sleep Arousals and Slow Wave Sleep. J Clin Sleep Med. 2016 Jan;12(1):19-24. doi: 10.5664/jcsm.5384.
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Shechter A, Grandner MA, St-Onge MP. The Role of Sleep in the Control of Food Intake. Am J Lifestyle Med. 2014 Nov 1;8(6):371-374. doi: 10.1177/1559827614545315. Epub 2014 Aug 6.
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St-Onge MP, Ross R, Parsons WD, Jones PJ. Medium-chain triglycerides increase energy expenditure and decrease adiposity in overweight men. Obes Res. 2003 Mar;11(3):395-402. doi: 10.1038/oby.2003.53.
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Shen W, Chen J, Gantz M, Velasquez G, Punyanitya M, Heymsfield SB. A single MRI slice does not accurately predict visceral and subcutaneous adipose tissue changes during weight loss. Obesity (Silver Spring). 2012 Dec;20(12):2458-63. doi: 10.1038/oby.2012.168. Epub 2012 Jun 25.
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Dhurandhar NV, Schoeller D, Brown AW, Heymsfield SB, Thomas D, Sorensen TI, Speakman JR, Jeansonne M, Allison DB; Energy Balance Measurement Working Group. Energy balance measurement: when something is not better than nothing. Int J Obes (Lond). 2015 Jul;39(7):1109-13. doi: 10.1038/ijo.2014.199. Epub 2014 Nov 13.
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St-Onge MP, Campbell A, Aggarwal B, Taylor JL, Spruill TM, RoyChoudhury A. Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects. Am Heart J. 2020 May;223:12-22. doi: 10.1016/j.ahj.2020.02.006. Epub 2020 Feb 8.
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RESULT
St-Onge MP, Campbell A, Salazar I, Pizinger T, Liao M, Aggarwal B. Information on Bedtimes and Wake Times Improves the Relation Between Self-Reported and Objective Assessments of Sleep in Adults. J Clin Sleep Med. 2019 Jul 15;15(7):1031-1036. doi: 10.5664/jcsm.7888.
Reference Type
RESULT
St-Onge MP, Campbell A, Zuraikat F, Cheng B, Shah R, Berger JS, Sampogna RV, Jelic S. Impact of change in bedtime variability on body composition and inflammation: secondary findings from the Go Red for Women Strategically Focused Research Network. Int J Obes (Lond). 2020 Aug;44(8):1803-1806. doi: 10.1038/s41366-020-0555-1. Epub 2020 Mar 5.
Reference Type
RESULT
Aggarwal B, Makarem N, Shah R, Emin M, Wei Y, St-Onge MP, Jelic S. Effects of Inadequate Sleep on Blood Pressure and Endothelial Inflammation in Women: Findings From the American Heart Association Go Red for Women Strategically Focused Research Network. J Am Heart Assoc. 2018 Jun 9;7(12):e008590. doi: 10.1161/JAHA.118.008590.
Reference Type
RESULT
Makarem N, Zuraikat FM, Scaccia SE, RoyChoudhury A, St-Onge MP. Sustained Mild Sleep Restriction Increases Blood Pressure in Women: An Update From the American Heart Association Go Red for Women Strategically Focused Research Network. Hypertension. 2021 May 5;77(5):e50-e52. doi: 10.1161/HYPERTENSIONAHA.120.16370. Epub 2021 Mar 29. No abstract available.
Reference Type
RESULT
Barragan R, Zuraikat FM, Tam V, Scaccia S, Cochran J, Li S, Cheng B, St-Onge MP. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics. Nutrients. 2021 Mar 5;13(3):852. doi: 10.3390/nu13030852.
Reference Type
RESULT
St-Onge MP, Aggarwal B, Allison MA, Berger JS, Castaneda SF, Catov J, Hochman JS, Hubel CA, Jelic S, Kass DA, Makarem N, Michos ED, Mosca L, Ouyang P, Park C, Post WS, Powers RW, Reynolds HR, Sears DD, Shah SJ, Sharma K, Spruill T, Talavera GA, Vaidya D. Go Red for Women Strategically Focused Research Network: Summary of Findings and Network Outcomes. J Am Heart Assoc. 2021 Feb;10(5):e019519. doi: 10.1161/JAHA.120.019519. Epub 2021 Feb 23.
Reference Type
RESULT
Petrov ME, Zuraikat FM, Cheng B, Aggarwal B, Jelic S, Laferrere B, St-Onge MP. Impact of sleep restriction on biomarkers of thyroid function: Two pooled randomized trials. Sleep Med. 2024 Dec;124:606-612. doi: 10.1016/j.sleep.2024.10.035. Epub 2024 Oct 30.
Reference Type
DERIVED
Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Apr;10(2):229-236. doi: 10.1016/j.sleh.2023.11.011. Epub 2024 Jan 16.
Reference Type
DERIVED
Barragan R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge MP. Paradoxical Effects of Prolonged Insufficient Sleep on Lipid Profile: A Pooled Analysis of 2 Randomized Trials. J Am Heart Assoc. 2023 Oct 17;12(20):e032078. doi: 10.1161/JAHA.123.032078. Epub 2023 Oct 10.
Reference Type
DERIVED
Shah R, Shah VK, Emin M, Gao S, Sampogna RV, Aggarwal B, Chang A, St-Onge MP, Malik V, Wang J, Wei Y, Jelic S. Mild sleep restriction increases endothelial oxidative stress in female persons. Sci Rep. 2023 Sep 16;13(1):15360. doi: 10.1038/s41598-023-42758-y.
Reference Type
DERIVED
Barragan R, Zuraikat FM, Tam V, RoyChoudhury A, St-Onge MP. Changes in eating patterns in response to chronic insufficient sleep and their associations with diet quality: a randomized trial. J Clin Sleep Med. 2023 Nov 1;19(11):1867-1875. doi: 10.5664/jcsm.10696.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AAAQ7638
Identifier Type: -
Identifier Source: org_study_id
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