Recruiting

Q-Collar

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT06826781

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Q30 Q-Collar

Not wearing Q-Collar

Study Details

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.

Conditions

Healthy

Study ID

NCT06826781

Start date

Jul 23, 2025

Status verified date

Oct, 2025

Completion date

Aug 23, 2026

Anticipated

Primary completion date

Jul 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cerebrovascular Control with Q-Collar

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.

placebo comparator: Cerebrovascular Control without Q-Collar

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.

Interventions

Q30 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-Collar

Participants will undergo the same study procedures without wearing the Q-Collar.

Primary outcome measure

  • Sit-to-Stand Test: Autoregulatory Slope [ Time Frame: 2 study visits within a 4 week time frame ]
  • Resistance Breathing Test: Autoregulatory Gain [ Time Frame: 2 study visits within a 4 week time frame ]
  • Graded Bike Test: Change in Cerebral Blood Flow [ Time Frame: 2 study visits within a 4 week time frame ]

Central Contacts and Locations

Central contacts

J. Andrew Taylor, MS, PhD

617-758-5503jandrew_taylor@hms.harvard.edu

Locations

Spaulding Rehabilitation Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Glen Picard, MS

617-758-5511GPICARD@PARTNERS.ORG

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

  • Q-Collar
  • Cerebrovascular Blood Flow Regulation
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2025-10-27.