HealthyNCT06826781
Evaluating Q-Collar Effects on Brain Blood Flow Control During Exercise
A study testing Q30 Q-Collar and Not wearing Q-Collar in people with Healthy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Q30 Q-Collar and Not wearing Q-Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to 23 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals between the ages of 18 to 30 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: Evaluating Q-Collar Effects on Cerebrovascular Control in Response to Exercise
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:
- 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?
- How does the Q-Collar affect brain blood flow during exercise?
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Q30 Q-Collar, Not wearing Q-Collar
- Keywords
- Q-Collar, Cerebrovascular Blood Flow Regulation, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q30 Q-CollarDevice
Also called Q-Collar
Participants will complete a series of tests (sit-to-stand, resistive breathing, and graded bike test) while wearing a Q-Collar.
Not wearing Q-CollarOther
Participants will undergo the same study procedures without wearing the Q-Collar.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Q30 Q-Collar |
| 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. Receives: Other: Not wearing Q-Collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 study visits within a 4 week time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start23 Jul 2025
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Why it stopped: staff and funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Andrew Taylor, Spaulding Rehabilitation Hospital
- Investigators
- J. Andrew Taylor, MS, PhD, Principal investigator, Harvard Medical School/Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826781
- Sponsor's protocol ID
- 2024P003589
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Q-Collar Effects on Cerebrovascular Control in Response to Exercise
- ClinicalTrials.gov ID
- NCT06826781
- Acronym / sponsor ID
- 2024P003589
- Conditions
- Healthy
- Keywords
- Q-Collar, Cerebrovascular Blood Flow Regulation, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: staff and funding issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cerebrovascular Control with Q-Collar | Experimental | Device: Q30 Q-CollarParticipants 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. |
| Cerebrovascular Control without Q-Collar | Placebo comparator | Other: Not wearing Q-CollarParticipants will undergo measurements of cerebral blood flow during changes in body position (sit-to-stand) and resistance breathing tasks without wearing a Q-collar. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individuals between the ages of 18 to 30 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q30 Q-CollarAlso: Q-CollarParticipants will complete a series of tests (sit-to-stand, resistive breathing, and graded bike test) while wearing a Q-Collar. | Device | Cerebrovascular Control with Q-Collar |
| Not wearing Q-CollarParticipants will undergo the same study procedures without wearing the Q-Collar. | Other | Cerebrovascular Control without Q-Collar |
Primary outcome
Sit-to-Stand Test: Autoregulatory Slope
Time frame: 2 study visits within a 4 week time frame
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.
Resistance Breathing Test: Autoregulatory Gain
Time frame: 2 study visits within a 4 week time frame
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.
Graded Bike Test: Change in Cerebral Blood Flow
Time frame: 2 study visits within a 4 week time frame
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.
Results and safety
The study was stopped early (reason given: staff and funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Andrew Taylor, MS, PhD principal investigator
Harvard Medical School/Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q30 Q-Collar and Not wearing Q-Collar in people with Healthy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: staff and funding issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit-to-Stand Test: Autoregulatory Slope (time frame: 2 study visits within a 4 week time frame). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.