Clinical trial NCT06201390: Stable Sleep Pattern Before Sleep Loss
Official title: Effect of Stable Sleep Patterns on Peripheral Vascular Function Following Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: sleep variability
blood pressure
sleep deprivation
vasodilation
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants 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. 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.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Women and men
* 35-64 years of age

Exclusion Criteria:

* obese based on BMI \>29 kg/m2
* night-shift work
* prior diagnosis of sleep apnea
* signs of insomnia using the Insomnia Symptom Questionnaire
* a 'poor sleeper' (global score ≥5) based on the Pittsburgh Sleep Quality Index
* taking medications that alter sleep
* personal history of stroke, coronary heart disease, diabetes mellitus
* taking antihypertensive medications
* smoker (including vaping)

Primary outcomes:
measure: Change in Peak Reactive Hyperemia
timeFrame: pre-intervention; immediately after the intervention
measure: Change in Arterial Stiffness
timeFrame: pre-intervention; immediately after the intervention
measure: Change in Blood Pressure Reactivity
timeFrame: pre-intervention; immediately after the intervention
measure: Change in Cerebral oxygenation
timeFrame: pre-intervention; immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Kinesiology and Sport Management building
state: Texas
Study officials:
affiliation: Texas Tech University
name: Joaquin U Gonzales, PhD
role: PRINCIPAL_INVESTIGATOR
References: