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Repeated Challenge of Insufficient Sleep: Endothelial Effects

Primary Purpose

Repeated Short Sleep Schedule

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repeated cycles of short sleep
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Repeated Short Sleep Schedule

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

normal sleep

cycles of sleep restriction

Arm Description

Subjects have 8 hours of sleep opportunity per night

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

Outcomes

Primary Outcome Measures

Vascular reactivity

Secondary Outcome Measures

Inflammation

Full Information

First Posted
January 30, 2012
Last Updated
October 19, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01523535
Brief Title
Repeated Challenge of Insufficient Sleep: Endothelial Effects
Official Title
Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Repeated Short Sleep Schedule

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants were randomized to condition. Vascular reactivity testing was performed by operator who was blind to condition and outcomes assessment from that testing was also blind.
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal sleep
Arm Type
Placebo Comparator
Arm Description
Subjects have 8 hours of sleep opportunity per night
Arm Title
cycles of sleep restriction
Arm Type
Experimental
Arm Description
subjects are exposed to bouts of reduced sleep duration. The sleep loss is the intervention (experimental challenge).
Intervention Type
Behavioral
Intervention Name(s)
repeated cycles of short sleep
Intervention Description
- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles
Primary Outcome Measure Information:
Title
Vascular reactivity
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Inflammation
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet M Mullington, Ph.D.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Repeated Challenge of Insufficient Sleep: Endothelial Effects

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