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Physiologic Effects of Sleep Restriction

Primary Purpose

Sleep Deprivation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

sleep restriction

About this trial

This is an interventional basic science trial for Sleep Deprivation focused on measuring sleep deprivation, sleep restriction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

sleep restriction

normal sleep

Arm Description

restricted sleep during the experimental period

normal sleep during the experimental period

Outcomes

Primary Outcome Measures

Change in blood pressure

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

Secondary Outcome Measures

Change in catecholamines

Change in catecholamines, measured during acclimation, experimental, and recovery

Change in endothelial function

Change in endothelial function, measured during acclimation, experimental, and recovery timepoints.

Change in baroreflex sensitivity

Change in baroreflex sensitivity, measured during acclimation, experimental, and recovery

Change in arterial stiffness

Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

Change in electrocardiographic characteristics

Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.

Change in markers of inflammation

Change in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.

Change in fat tissue characteristics

Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.

Full Information

NCT ID

NCT01433315

First Posted

August 15, 2011

Last Updated

January 18, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01433315

Brief Title

Physiologic Effects of Sleep Restriction

Official Title

Physiologic Effects of Sleep Restriction

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

April 27, 2017 (Actual)

Study Completion Date

April 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation

Keywords

sleep deprivation, sleep restriction

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sleep restriction

Arm Type

Experimental

Arm Description

restricted sleep during the experimental period

Arm Title

normal sleep

Arm Type

No Intervention

Arm Description

normal sleep during the experimental period

Intervention Type

Behavioral

Intervention Name(s)

sleep restriction

Intervention Description

restricted sleep

Primary Outcome Measure Information:

Title

Change in blood pressure

Description

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

Time Frame

throughout 16 days

Secondary Outcome Measure Information:

Title

Change in catecholamines

Description

Change in catecholamines, measured during acclimation, experimental, and recovery

Time Frame

throughout 16 days

Title

Change in endothelial function

Description

Change in endothelial function, measured during acclimation, experimental, and recovery timepoints.

Time Frame

throughout 16 days

Title

Change in baroreflex sensitivity

Description

Change in baroreflex sensitivity, measured during acclimation, experimental, and recovery

Time Frame

throughout 16 days

Title

Change in arterial stiffness

Description

Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

Time Frame

throughout 16 days

Title

Change in electrocardiographic characteristics

Description

Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.

Time Frame

throughout 16 days

Title

Change in markers of inflammation

Description

Change in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.

Time Frame

throughout 16 days

Title

Change in fat tissue characteristics

Description

Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.

Time Frame

throughout 16 days

Other Pre-specified Outcome Measures:

Title

Change in sleep architecture and sleepiness

Description

Change in sleep architecture and sleepiness, measured during acclimation, experimental, and recovery timepoints.

Time Frame

throughout 16 days

Title

Change in neurocognitive function

Description

Change in neurocognitive function, measured during acclimation, experimental, and recovery timepoints

Time Frame

throughout 16 days

Title

Change in cardiovascular reactivity

Description

Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.

Time Frame

throughout 16 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virend K Somers, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Physiologic Effects of Sleep Restriction

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