Effect of Total Sleep Deprivation on Vascular Function

NCT ID: NCT04535219

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-11

Study Completion Date

2022-08-02

Brief Summary

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Insufficient sleep is associated with an increased risk for cardiovascular disease. The causal mechanisms are currently unknown, but may include endothelial dysfunction. The purpose of this study is to examine the influence of sex and aging on the effects of total sleep deprivation on vascular function and whether exercise training attenuates these effects.

Detailed Description

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Conditions

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Sleep Deprivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A

Participants will have vascular function assessed following total sleep deprivation

Group Type EXPERIMENTAL

Supervised Total Sleep Deprivation

Intervention Type OTHER

Laboratory-monitored total sleep deprivation

Group B

Participants will have vascular function assessed following a full night of sleep

Group Type NO_INTERVENTION

No interventions assigned to this group

Group C

Participants will have vascular function assessed following total sleep deprivation preceded by exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)

Supervised Total Sleep Deprivation

Intervention Type OTHER

Laboratory-monitored total sleep deprivation

Group D

Participants will have vascular function assessed following a full night of sleep

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)

Intervention Type OTHER

Supervised Total Sleep Deprivation

Laboratory-monitored total sleep deprivation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males and females
* 20 to 30 and 50 to 60 years of age
* Females will be eumenorrheic at enrollment or postmenopausal for at least 1 year
* No major clinical disease (e.g., diabetes, cardiovascular, liver or chronic kidney disease) to minimize confounding of vascular measures
* Participants will be sedentary (≤3x per week of ≤30 minutes of aerobic exercise/session) or trained (≥5x per week of moderate/vigorous aerobic exercise training)

Exclusion Criteria

* Age \<20 or 31 to 49 or \>60 years
* Body mass index ≥30 kg/m\^2 because obesity may affect vascular function
* Use of medication that may affect vascular measures
* Hormone replacement therapy or hormonal contraceptives within past year
* Use of tobacco products (chewing tobacco, traditional or e-cigarettes) because they may influence vascular function
* Being perimenopausal, pregnant or lactating because may influence vascular function
* Being a shift worker because habitual sleep deprivation and altered circadian rhythm may influence vascular function.
* Not having an "intermediate" chronotype based on the Morningness-Eveningness Questionnaire (MEQ; score \<31 or \>69) because this would influence the effect of overnight sleep deprivation on vascular function.
* Sleep complaints based on the Pittsburgh Sleep Quality Index (PSQI; score \>5) because this would influence the effect of overnight sleep deprivation on vascular function.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Demetra Christou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201901937

Identifier Type: -

Identifier Source: org_study_id

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