ClinicalTrials.Veeva

Menu

Effect of Total Sleep Deprivation on Vascular Function

University of Florida logo

University of Florida

Status

Completed

Conditions

Sleep Deprivation

Treatments

Other: Supervised Total Sleep Deprivation
Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04535219
IRB201901937

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

23 participants in 4 patient groups

Group A
Experimental group
Description:
Participants will have vascular function assessed following total sleep deprivation
Treatment:
Other: Supervised Total Sleep Deprivation
Group B
No Intervention group
Description:
Participants will have vascular function assessed following a full night of sleep
Group C
Experimental group
Description:
Participants will have vascular function assessed following total sleep deprivation preceded by exercise
Treatment:
Other: Exercise
Other: Supervised Total Sleep Deprivation
Group D
No Intervention group
Description:
Participants will have vascular function assessed following a full night of sleep

Trial contacts and locations

1

Loading...

Central trial contact

Brady Holmer; Demetra Christou, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems