Physiologic Effects of Sleep Restriction

This study is currently recruiting participants.

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Contacts and Locations

Verified December 2016 by Virend Somers, Mayo Clinic

Sponsor:

Information provided by (Responsible Party):

Virend Somers, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01433315

First received: August 15, 2011

Last updated: December 12, 2016

Last verified: December 2016

History of Changes

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 (Participant, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Physiologic Effects of Sleep Restriction

Further study details as provided by Virend Somers, Mayo Clinic:

Primary Outcome Measures:

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.
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.
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
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:

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.
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.


Estimated Enrollment:	36
Study Start Date:	October 2011
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (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 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.

Eligibility


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.

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: 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

More Information


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:	December 12, 2016

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

ClinicalTrials.gov processed this record on June 28, 2017

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