This trial is active, not recruiting.

Condition repeated short sleep schedule
Treatment repeated cycles of short sleep
Sponsor Beth Israel Deaconess Medical Center
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date August 2011
End date December 2015
Trial size 52 participants
Trial identifier NCT01523535, 2010P-000365, R01HL106782


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
(Placebo Comparator)
Subjects have 8 hours of sleep opportunity per night
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
subjects are exposed to bouts of reduced sleep durations
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

Primary Outcomes

Vascular reactivity
time frame: 22 days

Secondary Outcomes

time frame: 22 days

Eligibility Criteria

Male or female participants from 25 years up to 55 years old.

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

Additional Information

Official title Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function
Principal investigator Janet M Mullington, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.