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Physiologic Effects of Sleep Restriction

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01433315
First received: August 15, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.


Condition Intervention
Sleep Deprivation
Behavioral: sleep restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Physiologic Effects of Sleep Restriction

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in blood pressure and autonomic function [ Time Frame: acclimation, experimental, and recovery timepoints (days 4, 13, and 16) ] [ Designated as safety issue: No ]
    Change in mean arterial blood pressure and autonomic function over 24 hours, measured during an acclimation, experimental, and recovery timepoints (days 4, 13, and 16) over the study period.

  • Change in markers of inflammation and endothelial function [ Time Frame: acclimation, experimental, and recovery timepoints (days 4, 13, and 16) ] [ Designated as safety issue: No ]
    Change in markers of inflammation and endothelial function, measured during an acclimation, experimental, and recovery timepoints (days 4, 13, and 16).

  • Change in neurocognitive deficits [ Time Frame: cognitive acclimation, experimental, and recovery timepoints (days 3, 12, and 15) ] [ Designated as safety issue: No ]
    Change in neurocognitive function measured by battery, measured during established cognitive acclimation, experimental, and recovery timepoints (days 3, 12, and 15)


Secondary Outcome Measures:
  • Change in fat tissue characteristics [ Time Frame: screening, experimental, and recovery timepoints (days 0, 13, and 16) ] [ Designated as safety issue: No ]
    Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.


Estimated Enrollment: 36
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sleep restriction
restricted sleep during the experimental period
Behavioral: sleep restriction
restricted sleep
No Intervention: normal sleep
normal sleep during the experimental period

Detailed Description:

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. Voluntary sleep restriction is common, with 28% of the US adult population reports getting 6 or fewer hours of sleep per night, and those who do are 24% more likely to have cardiovascular disease and have twice the risk of hypertension. Insufficient sleep may conceivably be one of the most common, and most preventable, cardiovascular risk factors. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators will combine our cardiovascular studies with state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the neurologic effects of sleep restriction. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-40 years
  • No chronic medical conditions other than seasonal or environmental allergies
  • On no prescription medications other than second generation antihistamines (Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices.
  • BMI 18.5-35 kg/m2
  • Both normotensive and prehypertensive people are eligible and will be studied
  • Not a current smoker or tobacco user
  • Not pregnant or breast feeding and not intending to become pregnant or breast feed

Exclusion Criteria:

  • The investigators will exclude subjects who have any medical or psychiatric disorders
  • History of anxiety or depression, and those taking any medications other than non-sedating antihistamines or oral contraceptives.
  • Those found to have depression on a depression screening tool (BDI-II) will be excluded. Current smokers will be excluded.
  • All female subjects will undergoing a screening pregnancy test and excluded if positive.
  • Subjects found to have significant sleep disorders will be excluded.
  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: NCT01433315

Contacts
Contact: Diane E Davison, MA, RN CPL@mayo.edu
Contact: Andrew D Calvin, MD, MPH

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Diane E Davison, MA, RN       CPL@mayo.edu   
Principal Investigator: Virend K Somers, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virend K Somers, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Virend Somers, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01433315     History of Changes
Other Study ID Numbers: 11-002121
Study First Received: August 15, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
sleep deprivation
sleep restriction

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders

ClinicalTrials.gov processed this record on November 24, 2014