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Physiologic Effects of Sleep Restriction

Physiologic Effects of Sleep Restriction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01433315
Enrollment
26
Registered
2011-09-13
Start date
2011-10-31
Completion date
2017-04-27
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Deprivation

Keywords

sleep deprivation, sleep restriction

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.

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.

Interventions

BEHAVIORALsleep restriction

restricted sleep

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressurethroughout 16 daysChange in mean arterial blood pressure over 24 hours, measured during acclimation, experimental, and recovery timepoints over the study period.

Secondary

MeasureTime frameDescription
Change in baroreflex sensitivitythroughout 16 daysChange in baroreflex sensitivity, measured during acclimation, experimental, and recovery
Change in electrocardiographic characteristicsthroughout 16 daysChange in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.
Change in markers of inflammationthroughout 16 daysChange in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.
Change in fat tissue characteristicsthroughout 16 daysChange in fat tissue characteristics, determined by analysis of a fat biopsy sample.
Change in catecholaminesthroughout 16 daysChange in catecholamines, measured during acclimation, experimental, and recovery
Change in endothelial functionthroughout 16 daysChange in endothelial function, measured during acclimation, experimental, and recovery timepoints.
Change in arterial stiffnessthroughout 16 daysChange in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

Other

MeasureTime frameDescription
Change in cardiovascular reactivitythroughout 16 daysChange in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.
Change in sleep architecture and sleepinessthroughout 16 daysChange in sleep architecture and sleepiness, measured during acclimation, experimental, and recovery timepoints.
Change in neurocognitive functionthroughout 16 daysChange in neurocognitive function, measured during acclimation, experimental, and recovery timepoints

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026