Stable Sleep Pattern Before Sleep Loss

Sleep Clinical Trial

Official title:

Effect of Stable Sleep Patterns on Peripheral Vascular Function Following Sleep Deprivation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201390
• Other study ID #: IRB2023-1166
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Texas Tech University
• Contact: Joaquin U Gonzales, PhD
• Phone: (806) 834-5944
• Email: joaquin.gonzales[@]ttu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Sleep consistency
Participants will be asked to maintain a consistent bed- and wake-time.

Locations

Country	Name	City	State
United States	Kinesiology and Sport Management building	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Reactive Hyperemia	Peak forearm blood flow will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Peak reactive hyperemia in the forearm (ml/100ml/min) will be measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow is considered the highest blood flow measurement after the blood pressure cuff is deflated.	pre-intervention; immediately after the intervention
Primary	Change in Arterial Stiffness	Arterial stiffness will be measured measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Carotid-femoral pulse wave velocity will be used as the measure of arterial stiffness. Radial arterial tonometry will be used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave will then used to calculate pulse wave velocity from transit time and carotid-femoral path length.	pre-intervention; immediately after the intervention
Primary	Change in Blood Pressure Reactivity	Blood pressure responses to isometric handgrip exercise will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Mean blood pressure reactivity will be measured using finger plethysmography during 2-minutes of isometric handgrip exercise followed by 3-minutes of post-exercise circulatory arrest.	pre-intervention; immediately after the intervention
Primary	Change in Cerebral oxygenation	Regional cerebral oxygenation during a cognitive task will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Oxy- and deoxy-hemoglobin levels in the prefrontal cortex will be measured using a near infrared spectroscopy (NIRs) device.	pre-intervention; immediately after the intervention