Physiologic Effects of Sleep Restriction
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ClinicalTrials.gov Identifier: NCT01433315 |
Recruitment Status
:
Recruiting
First Posted
: September 13, 2011
Last Update Posted
: March 5, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Deprivation | Behavioral: sleep restriction | Not Applicable |
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
|
- 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.
- 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.
- Change in arterial stiffness [ Time Frame: baseline to 16-day ]Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
- Change in cardiovascular reactivity [ Time Frame: baseline to 16-day ]Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.

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

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
Contact: CPL Lab | cplsleep@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: CPL LAB cplsleep@mayo.edu | |
Principal Investigator: Virend K Somers, MD, PhD |
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 |