Repeated Challenge of Insufficient Sleep: Endothelial Effects

October 19, 2020 updated by: Janet M Mullington, PhD, Beth Israel Deaconess Medical Center

Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: normal sleep
Subjects have 8 hours of sleep opportunity per night
- 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 duration. The sleep loss is the intervention (experimental challenge).
- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular reactivity
Time Frame: 22 days
22 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammation
Time Frame: 22 days
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Janet M Mullington, Ph.D., Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 30, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2010P000365
  • R01HL106782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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