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Clinical Trial Summary

Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.


Clinical Trial Description

Purpose and hypothesis The aim of this study will be to test the hypothesis that stable sleep, as defined by a consistent (low variability) bedtime and wake-time schedule, will diminish the negative effect of sleep deprivation on vascular function. Study design and procedures Thirty adults (15 men, 15 women) will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Bedtime and wake-times will be determined by the researchers, but individualized for each participant so that their usual sleep duration (based on self-report) is met. Sleep will be monitored throughout the study using research-grade motion sensors worn at the wrist. Resting blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation. Total sleep deprivation is a well-established experimental model to understand the acute effects of insufficient sleep on vascular function in humans. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06201390
Study type Interventional
Source Texas Tech University
Contact Joaquin U Gonzales, PhD
Phone (806) 834-5944
Email joaquin.gonzales@ttu.edu
Status Recruiting
Phase N/A
Start date January 25, 2024
Completion date January 31, 2025

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