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The goal of this clinical trial is to learn how the FDA-cleared Q-Collar device affects brain blood flow regulation during rest and exercise in healthy adults. The main questions this study aims to answer are:
Researchers will compare sessions where participants wear the Q-Collar to sessions where they do not wear the device to see if the Q-Collar improves brain blood flow during both rest and exercise.
Participants will:
We are doing this research to improve our understanding of how a FDA-cleared device, called the Q-Collar, affects brain blood flow regulation both at rest and in response to exercise. Participants will be asked to complete two study visits over a period of 1 to 4 weeks. Each visit will involve identical assessments, with the Q-Collar worn during one session and not during the other. The order of the sessions will be randomly assigned.
Each visit consists of three main tasks:
Standing Test (approximately 10 minutes): Participants will perform a series of movements, standing up from a seated position, while heart rate, breathing, and brain function are monitored. This test will be repeated three times per session.
Resistive Breathing Test (approximately 10 minutes): Using a mouthpiece that controls breathing difficulty, participants will breathe at specific depths and rates while sensors track gases, heart, lung, and brain activity. This task will be completed once per session.
Stationary Biking Exercise Test (approximately 30 minutes): Participants will perform an exercise test on a stationary bike while monitors measure heart rate, breathing gases, blood pressure, and brain blood flow. The test begins with a 2-minute warm-up, followed by progressively more challenging pedaling, with resistance adjusted based on body weight. Difficulty increases every 1 to 2 minutes until the required pace can no longer be maintained. Periodic ratings of exertion will be recorded. The session concludes with a 2-minute cool-down after maximum effort is reached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrovascular Control with Q-Collar | Experimental | Participants will undergo measurements of cerebral blood flow during changes in body position (sit-to-stand) and resistance breathing tasks while wearing a properly fitted Q-collar to evaluate how the Q-Collar affects cerebrovascular responses to rapid and sinusoidal shifts in blood pressure. |
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| Cerebrovascular Control without Q-Collar | Placebo Comparator | Participants will undergo measurements of cerebral blood flow during changes in body position (sit-to-stand) and resistance breathing tasks without wearing a Q-collar. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q30 Q-Collar | Device | Participants will complete a series of tests (sit-to-stand, resistive breathing, and graded bike test) while wearing a Q-Collar. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-Stand Test: Autoregulatory Slope | The slope of the autoregulatory curve, representing the change in cerebral blood flow in response to rapid shifts in blood pressure during the sit-to-stand transition. | 2 study visits within a 4 week time frame |
| Resistance Breathing Test: Autoregulatory Gain | The autoregulatory gain, which reflects the brain's ability to maintain stable cerebral blood flow during sinusoidal fluctuations in blood pressure induced by resistance breathing. | 2 study visits within a 4 week time frame |
| Graded Bike Test: Change in Cerebral Blood Flow | The change in cerebral blood flow velocity (CBFV) during the graded exercise test, assessed by Transcranial Doppler ultrasonography, indicating how cerebral blood flow responds to increasing physical exertion. | 2 study visits within a 4 week time frame |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. Andrew Taylor, MS, PhD | Contact | 617-758-5503 | jandrew_taylor@hms.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| J. Andrew Taylor, MS, PhD | Harvard Medical School/Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Recruiting | Cambridge | Massachusetts | 02138 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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The study will involve two identical study sessions at Spaulding Hospital Cambridge performed with or without the participant wearing a properly fitted Q-Collar. Both study sessions will be completed in a 4-week period, with the order of study sessions assigned randomly during the consent procedure. All studies will be performed between 8AM-1PM in the Cardiovascular Research Laboratory. Participants will be NPO for two hours, will have refrained from caffeine consumption for 24 hours, and from vigorous physical activity for 48 hours prior to study start time. Participants will have refrained from all medications and nutraceuticals for 48 hours prior to study. Women will be asked to provide a urine sample to determine that they are not pregnant. Upon arrival, subjects will be given 5 ml water per kg body mass to minimize potential effects of hydration status.
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| Not wearing Q-Collar | Other | Participants will undergo the same study procedures without wearing the Q-Collar. |
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