Physiologic Effects of Sleep Restriction

Sleep Deprivation Clinical Trial

Official title:

Physiologic Effects of Sleep Restriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433315
• Other study ID #: 11-002121
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: April 27, 2017

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Behavioral:
• sleep restriction
restricted sleep

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sleep architecture and sleepiness	Change in sleep architecture and sleepiness, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Other	Change in neurocognitive function	Change in neurocognitive function, measured during acclimation, experimental, and recovery timepoints	throughout 16 days
Other	Change in cardiovascular reactivity	Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Primary	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	Change in catecholamines	Change in catecholamines, measured during acclimation, experimental, and recovery	throughout 16 days
Secondary	Change in endothelial function	Change in endothelial function, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Secondary	Change in baroreflex sensitivity	Change in baroreflex sensitivity, measured during acclimation, experimental, and recovery	throughout 16 days
Secondary	Change in arterial stiffness	Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Secondary	Change in electrocardiographic characteristics	Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Secondary	Change in markers of inflammation	Change in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.	throughout 16 days
Secondary	Change in fat tissue characteristics	Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.	throughout 16 days

External Links

•   Mayo Clinic Clinical Trials