Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06201390
Other study ID # IRB2023-1166
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4