Clinical trial NCT04679051: Long Sleep Duration and Vascular Function
Official title: Effect of Pulsatile Pressure and Long Sleep Duration on Cerebral Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: sleep duration
blood pressure
vasodilation
cognitive function
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2020-12-22
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.
Primary purpose: PREVENTION

Brief summary: Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. The investigators hypothesize that long duration sleep has the ability to impair peripheral and cerebral vascular function in middle-aged to older adults.

Detailed description: The aim of this study is to compare the effect of long duration sleep (\>9 hours) to recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive function, and peripheral vasodilatory function will be measured before and after each sleep protocol. A secondary objective of this study is to understand whether aerobic exercise can improve vascular function under conditions of different sleep durations. This information will shed light upon the impact of sleep parameters on exercise-induced improvements in vascular function.

Eligibility criteria: Inclusion Criteria:

* recreationally active
* reporting no recent history of sleep problems
* not taking sleep-inducing medication
* not diabetic (fasting blood glucose \<126 mg/dL)

Exclusion Criteria:

* show symptoms of insomnia
* smoke
* have a personal history of stroke or diabetes
* take birth control pills

Primary outcomes:
measure: Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed
timeFrame: One night during each time in bed condition
measure: Change in Cerebral Vascular Reactivity After 11 Hours in Bed
timeFrame: Morning after one week of 8 and 11 hours in bed
measure: Change in Peak Reactive Hyperemia After 11 Hours in Bed
timeFrame: Morning after one week of 8 and 11 hours in bed
measure: Change in Arterial Stiffness After 11 Hours in Bed
timeFrame: Morning after one week of 8 and 11 hours in bed
Secondary outcomes:
measure: Change in Spatial Orientation After Aerobic Exercise
timeFrame: Baseline and after exercise
measure: Change in Executive Function After Aerobic Exercise
timeFrame: Baseline and after exercise
measure: Change in Mental Flexibility After Aerobic Exercise
timeFrame: Baseline and after exercise
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: Texas Tech University
name: Joaquin U Gonzales, PhD
role: PRINCIPAL_INVESTIGATOR
References: