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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stable sleep | Experimental | Participants will be asked to maintain a consistent sleep pattern for two weeks. |
|
| Habitual Sleep | No Intervention | Participants will be asked to maintain their usual sleep pattern for two weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep consistency | Behavioral | Participants will be asked to maintain a consistent bed- and wake-time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin U Gonzales, PhD | Texas Tech University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinesiology and Sport Management building | Lubbock | Texas | 79409-3011 | United States |
All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date.
All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date.
Open access
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2024 | Jan 26, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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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.
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |