Long Sleep Duration and Vascular Function

NCT ID: NCT04679051

Last Updated: 2023-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2021-06-30

Brief Summary

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Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. The investigators hypothesize that long duration sleep has the ability to impair peripheral and cerebral vascular function in middle-aged to older adults.

Detailed Description

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The aim of this study is to compare the effect of long duration sleep (\>9 hours) to recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive function, and peripheral vasodilatory function will be measured before and after each sleep protocol. A secondary objective of this study is to understand whether aerobic exercise can improve vascular function under conditions of different sleep durations. This information will shed light upon the impact of sleep parameters on exercise-induced improvements in vascular function.

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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8 hours time in bed

Participants will be asked to spend 8 hours time in bed with the aim of achieving one week of normal sleep duration (7 to 8 hours).

Group Type EXPERIMENTAL

Sleep duration

Intervention Type BEHAVIORAL

Participants will be asked to alter time in bed to achieve specified sleep durations.

11 hours time in bed

Participants will be asked to spend 11 hours time in bed with the aim of achieving one week of long duration sleep as defined as 9+ hours of sleep.

Group Type EXPERIMENTAL

Sleep duration

Intervention Type BEHAVIORAL

Participants will be asked to alter time in bed to achieve specified sleep durations.

Interventions

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Sleep duration

Participants will be asked to alter time in bed to achieve specified sleep durations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* recreationally active
* reporting no recent history of sleep problems
* not taking sleep-inducing medication
* not diabetic (fasting blood glucose \<126 mg/dL)

Exclusion Criteria

* show symptoms of insomnia
* smoke
* have a personal history of stroke or diabetes
* take birth control pills
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Joaquin U Gonzales, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joaquin U Gonzales, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

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Texas Tech University

Lubbock, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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19IPLOI34760579

Identifier Type: -

Identifier Source: org_study_id

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