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

NCT06826781 | Recruiting FDA Device

• 1 other identifier: 2024P003589
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Q-Collar; Cerebrovascular Blood Flow Regulation; Exercise

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Other: Not wearing Q-Collar

Interventions

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.

Also known as: Q-Collar

Cerebrovascular Control with Q-Collar

Not wearing Q-Collar OTHER

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

Cerebrovascular Control without Q-Collar

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• J. Andrew Taylor, MS, PhD

  Harvard Medical School/Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Andrew Taylor, MS, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 14, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): August 23, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1)