ClinicalTrials.gov
ClinicalTrials.gov Menu

Physiologic Effects of Sleep Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01433315
Recruitment Status : Recruiting
First Posted : September 13, 2011
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Deprivation Behavioral: sleep restriction Not Applicable

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 physiologic 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Physiologic Effects of Sleep Restriction
Study Start Date : October 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: sleep restriction
restricted sleep during the experimental period
Behavioral: sleep restriction
restricted sleep
No Intervention: normal sleep
normal sleep during the experimental period



Primary Outcome Measures :
  1. Change in blood pressure and autonomic function [ Time Frame: acclimation, experimental, and recovery timepoints ]
    Change in mean arterial blood pressure and autonomic function over 24 hours, measured during acclimation, experimental, and recovery timepoints over the study period.

  2. Change in markers of inflammation and endothelial function [ Time Frame: acclimation, experimental, and recovery timepoints ]
    Change in markers of inflammation and endothelial function, measured during acclimation, experimental, and recovery timepoints.

  3. Change in neurocognitive deficits [ Time Frame: cognitive acclimation, experimental, and recovery timepoints ]
    Change in neurocognitive function measured by battery, measured during established acclimation, experimental, and recovery timepoints

  4. Change in electrocardiographic characteristics [ Time Frame: acclimation, experimental, and recovery timepoints ]
    Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.


Secondary Outcome Measures :
  1. Change in fat tissue characteristics [ Time Frame: screening, experimental, and recovery timepoints ]
    Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.

  2. Change in sleep architecture and sleepiness [ Time Frame: acclimation, experimental, and recovery timepoints ]
    Change in sleep architecture and sleepiness, measured during acclimation, experimental, and recovery timepoints.

  3. Change in arterial stiffness [ Time Frame: baseline to 16-day ]
    Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

  4. Change in cardiovascular reactivity [ Time Frame: baseline to 16-day ]
    Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433315


Contacts
Contact: CPL Lab cplsleep@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: CPL LAB       cplsleep@mayo.edu   
Principal Investigator: Virend K Somers, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virend K Somers, MD, PhD Mayo Clinic

Responsible Party: Virend Somers, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01433315     History of Changes
Other Study ID Numbers: 11-002121
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Virend Somers, Mayo Clinic:
sleep deprivation
sleep restriction

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