Evaluating Q-Collar Effects on Brain Blood Flow Control During Exercise

Mass General Brigham

Status: Enrolling

Conditions: Healthy

Treatments: Other: Not wearing Q-Collar; Device: Q30 Q-Collar

Study type: Interventional

Funder types: Other

Identifiers

NCT06826781

2024P003589

Details and patient eligibility

About

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:

1. How does the Q-Collar affect brain blood flow when there are quick changes in blood pressure, like when standing up quickly, or when breathing against resistance?
2. How does the Q-Collar affect brain blood flow during exercise?

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:

• Complete two study visits, each 1 to 4 weeks apart.
• Perform a series of tasks, including standing tests, breathing tests, and exercise on a stationary bike, while their heart rate, brain blood flow, and other body functions are monitored.
• Wear the Q-Collar during one of the sessions and not wear it during the other session. The order of the sessions will be randomly assigned.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy individuals between the ages of 18 to 30 years old

Exclusion criteria

• History of concussion or other brain injury resulting in loss or alteration in consciousness or other change in cognition within 24 months of study visit
• High cardiac risk according to the American College of Sports Medicine (ACSM)11
• Ongoing active treatment with a cardioactive drug
• Inability to stand from a seated position unassisted
• History of a neurologic disorder or neurosurgery intervention
• Pregnancy
• Any current, serious, chronic medical or psychiatric disease that in the Principal Investigator's or co-investigator's judgment may interfere with study participation or data integrity
• Unable or unwilling to provide informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Cerebrovascular Control with Q-Collar

Experimental group

Description:

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.

Treatment:

Device: Q30 Q-Collar

Cerebrovascular Control without Q-Collar

Placebo Comparator group

Description:

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.

Treatment:

Other: Not wearing Q-Collar