Effect of Total Sleep Deprivation on Vascular Function

NCT04535219 | Completed DMC

• 1 other identifier: IRB201901937
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Central arterial stiffness

  through study completion, an average of 1 month

• Central arterial hemodynamics

  through study completion, an average of 1 month

Study Arms (4)

Group A

EXPERIMENTAL

Participants will have vascular function assessed following total sleep deprivation

Other: Supervised Total Sleep Deprivation

Group B

NO INTERVENTION

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

Group C

EXPERIMENTAL

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

Other: Exercise; Other: Supervised Total Sleep Deprivation

Group D

NO INTERVENTION

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

Interventions

Exercise OTHER

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

Group C

Supervised Total Sleep Deprivation OTHER

Laboratory-monitored total sleep deprivation

Group A; Group C

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Demetra Christou, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 1, 2020
• Study Start: July 11, 2021
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)