Effect of Total Sleep Deprivation on Vascular Function

Sleep Deprivation Clinical Trial

Official title:

Effect of Total Sleep Deprivation on Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535219
• Other study ID #: IRB201901937
• Status: Completed
• Phase: N/A
• Start date: July 11, 2021
• Est. completion date: August 2, 2022

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Exercise
60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)
• Supervised Total Sleep Deprivation
Laboratory-monitored total sleep deprivation

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 month
Primary	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.	through study completion, an average of 1 month
Secondary	Central arterial stiffness	The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.	through study completion, an average of 1 month
Secondary	Central arterial hemodynamics	The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.	through study completion, an average of 1 month