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OpenTrials
Completed

NCT Number: NCT04535219

Effect of Total Sleep Deprivation on Vascular Function

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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

Supervised Total Sleep Deprivation

Other

Laboratory-monitored total sleep deprivation

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2020
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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