- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06201390
Stable Sleep Pattern Before Sleep Loss
Effect of Stable Sleep Patterns on Peripheral Vascular Function Following Sleep Deprivation
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joaquin U Gonzales, PhD
- Phone Number: (806) 834-5944
- Email: joaquin.gonzales@ttu.edu
Study Locations
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Texas
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Lubbock, Texas, United States, 79409-3011
- Recruiting
- Kinesiology and Sport Management building
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Contact:
- Joaquin U Gonzales, PhD
- Phone Number: 806-834-5944
- Email: joaquin.gonzales@ttu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stable sleep
Participants will be asked to maintain a consistent sleep pattern for two weeks.
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Participants will be asked to maintain a consistent bed- and wake-time.
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No Intervention: Habitual Sleep
Participants will be asked to maintain their usual sleep pattern for two weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Peak Reactive Hyperemia
Time Frame: pre-intervention; immediately after the intervention
|
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
|
Change in Arterial Stiffness
Time Frame: pre-intervention; immediately after the intervention
|
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.
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pre-intervention; immediately after the intervention
|
Change in Blood Pressure Reactivity
Time Frame: pre-intervention; immediately after the intervention
|
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
|
Change in Cerebral oxygenation
Time Frame: pre-intervention; immediately after the intervention
|
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.
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pre-intervention; immediately after the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joaquin U Gonzales, PhD, Texas Tech University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2023-1166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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