Repeated Challenge of Insufficient Sleep: Endothelial Effects

NCT ID: NCT01523535

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Repeated Short Sleep Schedule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

normal sleep

Subjects have 8 hours of sleep opportunity per night

Group Type: PLACEBO_COMPARATOR

repeated cycles of short sleep

Intervention Type: BEHAVIORAL

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

cycles of sleep restriction

subjects are exposed to bouts of reduced sleep duration. The sleep loss is the intervention (experimental challenge).

Group Type: EXPERIMENTAL

repeated cycles of short sleep

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Janet M Mullington, PhD

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet M Mullington, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01HL106782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010P000365

Identifier Type: -

Identifier Source: org_study_id