Repeated Challenge of Insufficient Sleep: Endothelial Effects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01523535
First received: January 30, 2012
Last updated: November 13, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Repeated Short Sleep Schedule
Behavioral: repeated cycles of short sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Vascular reactivity [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammation [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: August 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: normal sleep
Subjects have 8 hours of sleep opportunity per night
Behavioral: 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
Experimental: cycles of sleep restriction
subjects are exposed to bouts of reduced sleep durations
Behavioral: 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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523535

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Janet M Mullington, Ph.D. Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01523535     History of Changes
Other Study ID Numbers: 2010P-000365  R01HL106782 
Study First Received: January 30, 2012
Last Updated: November 13, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 02, 2016