Repeated Challenge of Insufficient Sleep: Endothelial Effects
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Purpose
The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to stay. Americans are working more and more, frequently at multiple jobs. The pattern of short sleep during the week followed by attempts to recover on the weekend is in common practice, but we know little of the associated health risks. What is the cost in terms of increasing known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and is this cost compounded with repetition, without adequate recovery? Evidence is accumulating to suggest that short sleep duration is linked to the development of metabolic and inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the development of cardiovascular disease include impaired vascular function and inflammation. The current proposal is designed to investigate the effects of repeated periods of short nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep opportunity per night), and each cycle of short sleep followed by a single night of recovery sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation, and microcirculatory vasodilation will be assessed using perfusion imaging techniques. The dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function, will also be investigated.
| Condition | Intervention |
|---|---|
|
Repeated Short Sleep Schedule |
Behavioral: repeated cycles of short sleep |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function |
- Vascular reactivity [ Time Frame: 22 days ] [ Designated as safety issue: No ]
- Inflammation [ Time Frame: 22 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: normal sleep
Subjects have 8 hours of sleep opportunity per night
|
Behavioral: repeated cycles of short sleep
- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles
|
|
Experimental: cycles of sleep restriction
subjects are exposed to bouts of reduced sleep durations
|
Behavioral: repeated cycles of short sleep
- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles
|
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy volunteers
- Regular sleep-wake schedule
Exclusion Criteria:
- Diseases or medical conditions, including sleep disorders
- Current smoking
- Pregnant or nursing
- Recent time zone travel or shift work
- Regular medication use
- High blood pressure
Contacts and Locations| Contact: Cait Estes | 617-667-5243 | cestes@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Caitlin Estes, BSc 617-667-5243 CEstes@bidmc.harvard.edu | |
| Principal Investigator: | Janet M Mullington, Ph.D. | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01523535 History of Changes |
| Other Study ID Numbers: | 2010P-000365, R01HL106782 |
| Study First Received: | January 30, 2012 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on May 23, 2013