- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01523535
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
Conditions
Intervention / Treatment
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
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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.
Collaborators
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
Additional Relevant MeSH Terms
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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