Effect of Total Sleep Deprivation on Vascular Function

August 25, 2023 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Participants will have vascular function assessed following total sleep deprivation
Laboratory-monitored total sleep deprivation
No Intervention: Group B
Participants will have vascular function assessed following a full night of sleep
Experimental: Group C
Participants will have vascular function assessed following total sleep deprivation preceded by exercise
Laboratory-monitored total sleep deprivation
60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)
No Intervention: Group D
Participants will have vascular function assessed following a full night of sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: through study completion, an average of 1 month
Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to ~250 mmHg for 5 minutes followed by rapid deflation.
through study completion, an average of 1 month
Microvascular function
Time Frame: through study completion, an average of 1 month
Microvascular function will be assessed using the forearm blood flow response to submaximal handgrip exercise. Brachial artery blood flow and diameter will be assessed using Doppler ultrasound.
through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central arterial stiffness
Time Frame: through study completion, an average of 1 month
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
through study completion, an average of 1 month
Central arterial hemodynamics
Time Frame: through study completion, an average of 1 month
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Demetra Christou, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2021

Primary Completion (Actual)

August 2, 2022

Study Completion (Actual)

August 2, 2022

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB201901937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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