Clinical trial NCT06826781: Evaluating Q-Collar Effects on Brain Blood Flow Control During Exercise
Official title: Evaluating Q-Collar Effects on Cerebrovascular Control in Response to Exercise
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Q-Collar
Cerebrovascular Blood Flow Regulation
Exercise
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sit-to-Stand Test: Autoregulatory Slope
timeFrame: 2 study visits within a 4 week time frame
measure: Resistance Breathing Test: Autoregulatory Gain
timeFrame: 2 study visits within a 4 week time frame
measure: Graded Bike Test: Change in Cerebral Blood Flow
timeFrame: 2 study visits within a 4 week time frame
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School/Spaulding Rehabilitation Hospital
name: J. Andrew Taylor, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: