- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535219
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
Intervention / Treatment
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
- Name: Brady Holmer
- Email: ICPL@hhp.ufl.edu
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.
Sponsor
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
Additional Relevant MeSH Terms
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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