SleepNCT02835261
Impact of Sleep Restriction in Women
A study testing Sleep Restriction in people with Sleep and Cardiovascular Disease, run by Columbia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Cardiovascular Disease, Obesity
- What is being tested?
- Sleep Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Obesity Nutrition Research Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Cardiovascular Disease, Obesity
- Being tested
- Sleep Restriction
- Keywords
- Obesity, Metabolic Disorders
- Medical subject headings
- Cardiovascular Diseases, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionOther
Mild sleep restriction (-1.5 h/night) over a period of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Habitual Sleep (HS) | No intervention | During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. |
| Sleep Restriction (SR) | Experimental | 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. Receives: Other: Sleep Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance
Oral glucose tolerance test
Measured: baseline to 6 weeks
Change in blood pressure
24-hour ambulatory blood pressure; weekly office blood pressure
Measured: baseline to 6 weeks
Flow-mediated dilatation
Endpoint FMD
Measured: baseline to 6 weeks
Secondary outcomes (10)
Change in Adiposity
Body composition measured by magnetic resonance imaging
Measured: baseline to 6 weeks
Change in physical activity levels
Time in various behaviors: sedentary, light, moderate, moderate-to-vigorous physical activity
Measured: baseline to 6 weeks
C-reactive protein
Inflammatory markers
Measured: Weeks 0, 3, 4, and 6
Interleukin-6
Inflammatory markers
Measured: Weeks 0, 3, 4, and 6
Tumor necrosis factor
Inflammatory markers
Measured: Weeks 0, 3, 4, and 6
T cell reactivity to viral loads
Immune markers
Measured: Weeks 0 and 6
Cholesterol
Total, low-density, and high-density lipoprotein
Measured: Weeks 0 and 6
Triglycerides
Lipidemia
Measured: Weeks 0 and 6
Endothelial cell oxidative stress
redox sensitive fluorogenic probe fluorescence intensity
Measured: Baseline to 6 weeks
Endothelial inflammation
NF-κB nuclear fluorescence area
Measured: baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (85)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University-New York Obesity Nutrition Research CenterSanja Jelic, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835261
- Sponsor's protocol ID
- AAAQ7638
- Status last verified
- Oct 2025
- First submitted
- 21 Jun 2016
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with other researchers upon request
Publications
Jackowska M, Steptoe A. Sleep and future cardiovascular risk: prospective analysis from the English Longitudinal Study of Ageing. Sleep Med. 2015 Jun;16(6):768-74. doi: 10.1016/j.sleep.2015.02.530. Epub 2015 Mar 9.
PubMed 25934538Wu MC, Yang YC, Wu JS, Wang RH, Lu FH, Chang CJ. Short sleep duration associated with a higher prevalence of metabolic syndrome in an apparently healthy population. Prev Med. 2012 Oct;55(4):305-309. doi: 10.1016/j.ypmed.2012.07.013. Epub 2012 Jul 27.
PubMed 22846501Ohkuma T, Fujii H, Iwase M, Ogata-Kaizu S, Ide H, Kikuchi Y, Idewaki Y, Jodai T, Hirakawa Y, Nakamura U, Kitazono T. U-shaped association of sleep duration with metabolic syndrome and insulin resistance in patients with type 2 diabetes: the Fukuoka Diabetes Registry. Metabolism. 2014 Apr;63(4):484-91. doi: 10.1016/j.metabol.2013.12.001. Epub 2013 Dec 7.
PubMed 24411997Chaput JP, McNeil J, Despres JP, Bouchard C, Tremblay A. Seven to eight hours of sleep a night is associated with a lower prevalence of the metabolic syndrome and reduced overall cardiometabolic risk in adults. PLoS One. 2013 Sep 5;8(9):e72832. doi: 10.1371/journal.pone.0072832. eCollection 2013.
PubMed 24039808Hall MH, Muldoon MF, Jennings JR, Buysse DJ, Flory JD, Manuck SB. Self-reported sleep duration is associated with the metabolic syndrome in midlife adults. Sleep. 2008 May;31(5):635-43. doi: 10.1093/sleep/31.5.635.
PubMed 18517034Chaput JP, McNeil J, Despres JP, Bouchard C, Tremblay A. Short sleep duration as a risk factor for the development of the metabolic syndrome in adults. Prev Med. 2013 Dec;57(6):872-7. doi: 10.1016/j.ypmed.2013.09.022. Epub 2013 Oct 5.
PubMed 24099879Cappuccio FP, Taggart FM, Kandala NB, Currie A, Peile E, Stranges S, Miller MA. Meta-analysis of short sleep duration and obesity in children and adults. Sleep. 2008 May;31(5):619-26. doi: 10.1093/sleep/31.5.619.
PubMed 18517032Redline S, Foody J. Sleep disturbances: time to join the top 10 potentially modifiable cardiovascular risk factors? Circulation. 2011 Nov 8;124(19):2049-51. doi: 10.1161/CIRCULATIONAHA.111.062190. No abstract available.
PubMed 22064955Robertson MD, Russell-Jones D, Umpleby AM, Dijk DJ. Effects of three weeks of mild sleep restriction implemented in the home environment on multiple metabolic and endocrine markers in healthy young men. Metabolism. 2013 Feb;62(2):204-11. doi: 10.1016/j.metabol.2012.07.016. Epub 2012 Sep 15.
PubMed 22985906Hoevenaar-Blom MP, Spijkerman AM, Kromhout D, Verschuren WM. Sufficient sleep duration contributes to lower cardiovascular disease risk in addition to four traditional lifestyle factors: the MORGEN study. Eur J Prev Cardiol. 2014 Nov;21(11):1367-75. doi: 10.1177/2047487313493057. Epub 2013 Jul 3.
PubMed 23823570Ford ES. Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc. 2014 Dec 2;3(6):e001454. doi: 10.1161/JAHA.114.001454.
PubMed 25468656Canivet C, Nilsson PM, Lindeberg SI, Karasek R, Ostergren PO. Insomnia increases risk for cardiovascular events in women and in men with low socioeconomic status: a longitudinal, register-based study. J Psychosom Res. 2014 Apr;76(4):292-9. doi: 10.1016/j.jpsychores.2014.02.001. Epub 2014 Feb 11.
PubMed 24630179Sands-Lincoln M, Loucks EB, Lu B, Carskadon MA, Sharkey K, Stefanick ML, Ockene J, Shah N, Hairston KG, Robinson JG, Limacher M, Hale L, Eaton CB. Sleep duration, insomnia, and coronary heart disease among postmenopausal women in the Women's Health Initiative. J Womens Health (Larchmt). 2013 Jun;22(6):477-86. doi: 10.1089/jwh.2012.3918. Epub 2013 May 7.
PubMed 23651054Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun;32(12):1484-92. doi: 10.1093/eurheartj/ehr007. Epub 2011 Feb 7.
PubMed 21300732Cappuccio FP, Stranges S, Kandala NB, Miller MA, Taggart FM, Kumari M, Ferrie JE, Shipley MJ, Brunner EJ, Marmot MG. Gender-specific associations of short sleep duration with prevalent and incident hypertension: the Whitehall II Study. Hypertension. 2007 Oct;50(4):693-700. doi: 10.1161/HYPERTENSIONAHA.107.095471. Epub 2007 Sep 4.
PubMed 17785629
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Restriction on Cardiometabolic Risk Factors in Pre vs Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02835261
- Acronym / sponsor ID
- AAAQ7638
- Conditions
- Sleep, Cardiovascular Disease, Obesity
- Keywords
- Obesity, Metabolic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual Sleep (HS) | No intervention | –During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. |
| Sleep Restriction (SR) | Experimental | Other: Sleep RestrictionDuring 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep RestrictionMild sleep restriction (-1.5 h/night) over a period of 6 weeks | Other | Sleep Restriction (SR) |
Primary outcome
Change in glucose tolerance
Time frame: baseline to 6 weeks
Oral glucose tolerance test
Change in blood pressure
Time frame: baseline to 6 weeks
24-hour ambulatory blood pressure; weekly office blood pressure
Flow-mediated dilatation
Time frame: baseline to 6 weeks
Endpoint FMD
10 secondary outcomes
Change in Adiposity
Time frame: baseline to 6 weeks
Change in physical activity levels
Time frame: baseline to 6 weeks
C-reactive protein
Time frame: Weeks 0, 3, 4, and 6
Interleukin-6
Time frame: Weeks 0, 3, 4, and 6
Tumor necrosis factor
Time frame: Weeks 0, 3, 4, and 6
T cell reactivity to viral loads
Time frame: Weeks 0 and 6
Cholesterol
Time frame: Weeks 0 and 6
Triglycerides
Time frame: Weeks 0 and 6
Endothelial cell oxidative stress
Time frame: Baseline to 6 weeks
Endothelial inflammation
Time frame: baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Background: PubMed 25934538Jackowska M, Steptoe A. Sleep and future cardiovascular risk: prospective analysis from the English Longitudinal Study of Ageing. Sleep Med. 2015 Jun;16(6):768-74. doi: 10.1016/j.sleep.2015.02.530. Epub 2015 Mar 9.
- Background: PubMed 22846501Wu MC, Yang YC, Wu JS, Wang RH, Lu FH, Chang CJ. Short sleep duration associated with a higher prevalence of metabolic syndrome in an apparently healthy population. Prev Med. 2012 Oct;55(4):305-309. doi: 10.1016/j.ypmed.2012.07.013. Epub 2012 Jul 27.
- Background: PubMed 24411997Ohkuma T, Fujii H, Iwase M, Ogata-Kaizu S, Ide H, Kikuchi Y, Idewaki Y, Jodai T, Hirakawa Y, Nakamura U, Kitazono T. U-shaped association of sleep duration with metabolic syndrome and insulin resistance in patients with type 2 diabetes: the Fukuoka Diabetes Registry. Metabolism. 2014 Apr;63(4):484-91. doi: 10.1016/j.metabol.2013.12.001. Epub 2013 Dec 7.
- Background: PubMed 24039808Chaput JP, McNeil J, Despres JP, Bouchard C, Tremblay A. Seven to eight hours of sleep a night is associated with a lower prevalence of the metabolic syndrome and reduced overall cardiometabolic risk in adults. PLoS One. 2013 Sep 5;8(9):e72832. doi: 10.1371/journal.pone.0072832. eCollection 2013.
- Background: PubMed 18517034Hall MH, Muldoon MF, Jennings JR, Buysse DJ, Flory JD, Manuck SB. Self-reported sleep duration is associated with the metabolic syndrome in midlife adults. Sleep. 2008 May;31(5):635-43. doi: 10.1093/sleep/31.5.635.
- Background: PubMed 24099879Chaput JP, McNeil J, Despres JP, Bouchard C, Tremblay A. Short sleep duration as a risk factor for the development of the metabolic syndrome in adults. Prev Med. 2013 Dec;57(6):872-7. doi: 10.1016/j.ypmed.2013.09.022. Epub 2013 Oct 5.
- Background: PubMed 18517032Cappuccio FP, Taggart FM, Kandala NB, Currie A, Peile E, Stranges S, Miller MA. Meta-analysis of short sleep duration and obesity in children and adults. Sleep. 2008 May;31(5):619-26. doi: 10.1093/sleep/31.5.619.
- Background: PubMed 22064955Redline S, Foody J. Sleep disturbances: time to join the top 10 potentially modifiable cardiovascular risk factors? Circulation. 2011 Nov 8;124(19):2049-51. doi: 10.1161/CIRCULATIONAHA.111.062190. No abstract available.
- Background: PubMed 22985906Robertson MD, Russell-Jones D, Umpleby AM, Dijk DJ. Effects of three weeks of mild sleep restriction implemented in the home environment on multiple metabolic and endocrine markers in healthy young men. Metabolism. 2013 Feb;62(2):204-11. doi: 10.1016/j.metabol.2012.07.016. Epub 2012 Sep 15.
- Background: PubMed 23823570Hoevenaar-Blom MP, Spijkerman AM, Kromhout D, Verschuren WM. Sufficient sleep duration contributes to lower cardiovascular disease risk in addition to four traditional lifestyle factors: the MORGEN study. Eur J Prev Cardiol. 2014 Nov;21(11):1367-75. doi: 10.1177/2047487313493057. Epub 2013 Jul 3.
- Background: PubMed 25468656Ford ES. Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc. 2014 Dec 2;3(6):e001454. doi: 10.1161/JAHA.114.001454.
- Background: PubMed 24630179Canivet C, Nilsson PM, Lindeberg SI, Karasek R, Ostergren PO. Insomnia increases risk for cardiovascular events in women and in men with low socioeconomic status: a longitudinal, register-based study. J Psychosom Res. 2014 Apr;76(4):292-9. doi: 10.1016/j.jpsychores.2014.02.001. Epub 2014 Feb 11.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Pierre St-Onge, PhD principal investigator
Columbia University-New York Obesity Nutrition Research Center
Sanja Jelic, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction in people with Sleep and Cardiovascular Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance (time frame: baseline to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835261, which also lists 85 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.