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Completed

NCT Number: NCT01523535

Repeated Challenge of Insufficient Sleep: Endothelial Effects

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

Due to work, family, social and community obligations, millions of Americans cut back on sleep for several nights in a row before having an opportunity to catch up. When the opportunity does arise, it may only be for a single night, before the cycle of insufficient sleep repeats. This study investigated what happens to human biology when insufficient sleep becomes chronic and opportunities for recovery sleep are intermittent. It also investigated recovery sleep itself, and the biological processes involved in reversing the effects of an accumulated sleep deficit due to insufficient sleep duration.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repeated cycles of short sleep

Behavioral
  • 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles

Primary outcomes

  1. Vascular reactivity

    Time frame: 22 days

Secondary outcomes

  1. Inflammation

    Time frame: 22 days

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2012
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.