Physiologic Effects of Sleep Restriction
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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 |
- 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)
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01433315
| Contact: CPL Lab | CPL@mayo.edu |
| 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 | |
| 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: | February 2, 2015 |
| 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 February 27, 2015