Back to resultsEffect of Total Sleep Deprivation on Vascular Function
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Supervised Total Sleep Deprivation
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation
Eligibility Criteria
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.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Group A
Group B
Group C
Group D
Arm Description
Participants will have vascular function assessed following total sleep deprivation
Participants will have vascular function assessed following a full night of sleep
Participants will have vascular function assessed following total sleep deprivation preceded by exercise
Participants will have vascular function assessed following a full night of sleep
Outcomes
Primary Outcome Measures
Endothelial function
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.
Microvascular function
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.
Secondary Outcome Measures
Central arterial stiffness
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Central arterial hemodynamics
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04535219
Brief Title
Effect of Total Sleep Deprivation on Vascular Function
Official Title
Effect of Total Sleep Deprivation on Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
August 2, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants will have vascular function assessed following total sleep deprivation
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Participants will have vascular function assessed following a full night of sleep
Arm Title
Group C
Arm Type
Experimental
Arm Description
Participants will have vascular function assessed following total sleep deprivation preceded by exercise
Arm Title
Group D
Arm Type
No Intervention
Arm Description
Participants will have vascular function assessed following a full night of sleep
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)
Intervention Type
Other
Intervention Name(s)
Supervised Total Sleep Deprivation
Intervention Description
Laboratory-monitored total sleep deprivation
Primary Outcome Measure Information:
Title
Endothelial function
Description
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.
Time Frame
through study completion, an average of 1 month
Title
Microvascular function
Description
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.
Time Frame
through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Central arterial stiffness
Description
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Time Frame
through study completion, an average of 1 month
Title
Central arterial hemodynamics
Description
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Time Frame
through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demetra Christou, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Total Sleep Deprivation on Vascular Function
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