Physiologic Effects of Sleep Restriction

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.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation
• Intervention / Treatment: Behavioral: sleep restriction

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
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Change in mean arterial blood pressure over 24 hours, measured during acclimation, experimental, and recovery timepoints over the study period.	throughout 16 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in catecholamines	Change in catecholamines, measured during acclimation, experimental, and recovery	throughout 16 days
Change in endothelial function	Change in endothelial function, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Change in baroreflex sensitivity	Change in baroreflex sensitivity, measured during acclimation, experimental, and recovery	throughout 16 days
Change in arterial stiffness	Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Change in electrocardiographic characteristics	Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Change in markers of inflammation	Change in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Change in fat tissue characteristics	Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.	throughout 16 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep architecture and sleepiness	Change in sleep architecture and sleepiness, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Change in neurocognitive function	Change in neurocognitive function, measured during acclimation, experimental, and recovery timepoints	throughout 16 days
Change in cardiovascular reactivity	Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): April 27, 2017
• Study Completion (ACTUAL): April 27, 2017

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (ESTIMATE): September 13, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: sleep deprivation; sleep restriction
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: 11-002121