Physiological Responses to High-Intensity ExerciseNCT07808710
Effects of the Q-Collar During High-Intensity Cycling Exercise
A study testing Q-Collar™ in people with Physiological Responses to High-Intensity Exercise, run by University of Northern Iowa at 1 site in United States.
Trial summary
This study examined the effects of wearing the Q-Collar during high-intensity cycling exercise. Eleven recreationally trained male participants completed two 5-kilometer cycling time trials: one while wearing the Q-Collar and one without the Q-Collar. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Responses to High-Intensity Exercise
- What is being tested?
- Q-Collar™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 8 May 2024
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants
- 18-35 years old
- Recreationally trained
- Provided written informed consent
- Achieved a maximal oxygen consumption (VO₂max) classified as "good" or "excellent" during cardiopulmonary exercise testing
Who cannot join
- Failure to meet the required "good" or "excellent" VO₂max classification during cardiopulmonary exercise testing
- Outside age range
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Northern Iowa
Cedar Falls, Iowa, 50614
About this study
Official title: Cardiovascular, Cerebral, and Performance Responses to Q-Collar™ Use in a 5-km Cycling Time Trial
This study examined the effects of wearing the Q-Collar during high-intensity cycling exercise. Eleven recreationally trained male participants completed two 5-kilometer cycling time trials: one while wearing the Q-Collar and one without the Q-Collar. During and after each trial, researchers measured cardiovascular responses, brain oxygenation, blood lactate, perceived exertion, cognitive performance, and cycling performance. The purpose of the study was to determine whether wearing the Q-Collar affects physiological responses, cognitive function, or performance during high-intensity exercise.
Read the detailed description
This randomized crossover study examined the effects of Q-Collar use during high-intensity cycling exercise. Recreationally trained male participants completed two laboratory testing sessions in randomized order: a 5-kilometer cycling time trial while wearing the Q-Collar and a 5-kilometer cycling time trial without the Q-Collar. The Q-Collar applies mild bilateral compression to the internal jugular veins and is designed to increase cerebral blood volume.
During each trial, cardiovascular responses were assessed continuously, while prefrontal cortex oxygenation was measured using functional near-infrared spectroscopy. Blood lactate and ratings of perceived exertion were assessed during exercise, and cognitive performance was evaluated before and after each cycling trial. Cycling performance was also recorded.
The study was designed to determine whether wearing the Q-Collar alters physiological responses to high-intensity exercise, particularly cardiovascular function and prefrontal cortex oxygenation, and whether these responses are accompanied by changes in cognitive or cycling performance. The crossover design allowed each participant to complete both conditions and therefore serve as his own control.
- Being tested
- Q-Collar™
- Keywords
- Q-collar, Jugular vein compression, Functional near-infrared spectroscopy, Prefrontal cortex oxygenation, Cognitive performance, Cycling performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-Collar™Device
The Q-Collar™ is a wearable neck device that applies mild bilateral compression to the internal jugular veins. Participants wore the Q-Collar during a 5-kilometer cycling time trial. The device was individually fitted according to manufacturer guidelines and remained in place throughout the exercise trial.
| Study group | Role | What they receive |
|---|---|---|
| Q-Collar Then Control | Experimental | Participants completed a 5-kilometer cycling time trial while wearing the Q-Collar, followed by a control 5-kilometer cycling time trial without the Q-Collar after a washout period of at least 72 hours. Receives: Device: Q-Collar™ |
| Control Then Q-Collar | Experimental | Participants completed a control 5-kilometer cycling time trial without the Q-Collar, followed by a 5-kilometer cycling time trial while wearing the Q-Collar after a washout period of at least 72 hours. Receives: Device: Q-Collar™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prefrontal Cortex Oxygenation
Changes in prefrontal cortex oxygenated hemoglobin were continuously measured using functional near-infrared spectroscopy during 5-kilometer cycling time trials performed with and without the Q-Collar. Data were evaluated across kilometer time points.
Measured: All throughout each 5-kilometer cycling time trial, approximately 10 minutes
Secondary outcomes (7)
Cycling Time-Trial Performance
Time in seconds required to complete the 5-kilometer cycling time trial was recorded for the Q-Collar and control conditions.
Measured: At completion of each 5-kilometer cycling time trial, approximately 30 seconds
Choice Reaction Time
Choice reaction time was assessed using a computerized Stroop task. Reaction time and response accuracy were evaluated across the Q-Collar and control conditions.
Measured: At baseline, 5 minutes into exercise, immediately post-exercise, and 10 minutes post-exercise during each experimental visit, approximately 2 minutes at each time point
Heart Rate
Heart rate was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
Measured: During each 5-kilometer cycling time trial, approximately 10 minutes
Stroke Volume
Stroke volume was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
Measured: During each 5-kilometer cycling time trial, approximately 10 minutes
Cardiac Output
Cardiac output was continuously assessed using cardiac impedance and compared across the Q-Collar and control conditions.
Measured: During each 5-kilometer cycling time trial, approximately 10 minutes
Blood Lactate
Blood lactate concentration (mmol/L) was measured from an earlobe capillary blood sample immediately following each cycling time trial.
Measured: Immediately following each 5-kilometer cycling time trial, approximately 1 minute
Rating of Perceived Exertion
Rating of perceived exertion was assessed using the Borg 6-20 scale immediately following each 5-kilometer cycling time trial.
Measured: Immediately following each 5-kilometer cycling time trial, approximately 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start20 Mar 2024
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Responses to High-Intensity ExerciseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants completed two 5-kilometer cycling time trials in randomized, counterbalanced order: one while wearing the Q-Collar and one without the Q-Collar. Each participant served as his own control, with at least 72 hours between conditions.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Northern Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808710
- Sponsor's protocol ID
- IRB-FY24-97
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current plan for public sharing of individual participant data; however, de-identified data may be considered upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular, Cerebral, and Performance Responses to Q-Collar™ Use in a 5-km Cycling Time Trial
- ClinicalTrials.gov ID
- NCT07808710
- Acronym / sponsor ID
- IRB-FY24-97
- Keywords
- Q-collar, Jugular vein compression, Functional near-infrared spectroscopy, Prefrontal cortex oxygenation, Cognitive performance, Cycling performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Northern IowaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 9 Sep 2026 (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.
This study examined the effects of wearing the Q-Collar during high-intensity cycling exercise. Eleven recreationally trained male participants completed two 5-kilometer cycling time trials: one while wearing the Q-Collar and one without the Q-Collar. During and after each trial, researchers measured cardiovascular responses, brain oxygenation, blood lactate, perceived exertion, cognitive performance, and cycling performance. The purpose of the study was to determine whether wearing the Q-Collar affects physiological responses, cognitive function, or performance during high-intensity exercise.
Detailed description
This randomized crossover study examined the effects of Q-Collar use during high-intensity cycling exercise. Recreationally trained male participants completed two laboratory testing sessions in randomized order: a 5-kilometer cycling time trial while wearing the Q-Collar and a 5-kilometer cycling time trial without the Q-Collar. The Q-Collar applies mild bilateral compression to the internal jugular veins and is designed to increase cerebral blood volume.
During each trial, cardiovascular responses were assessed continuously, while prefrontal cortex oxygenation was measured using functional near-infrared spectroscopy. Blood lactate and ratings of perceived exertion were assessed during exercise, and cognitive performance was evaluated before and after each cycling trial. Cycling performance was also recorded.
The study was designed to determine whether wearing the Q-Collar alters physiological responses to high-intensity exercise, particularly cardiovascular function and prefrontal cortex oxygenation, and whether these responses are accompanied by changes in cognitive or cycling performance. The crossover design allowed each participant to complete both conditions and therefore serve as his own control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants completed two 5-kilometer cycling time trials in randomized, counterbalanced order: one while wearing the Q-Collar and one without the Q-Collar. Each participant served as his own control, with at least 72 hours between conditions.
| Arm | Type | Receives |
|---|---|---|
| Q-Collar Then Control | Experimental | Device: Q-Collar™Participants completed a 5-kilometer cycling time trial while wearing the Q-Collar, followed by a control 5-kilometer cycling time trial without the Q-Collar after a washout period of at least 72 hours. |
| Control Then Q-Collar | Experimental | Device: Q-Collar™Participants completed a control 5-kilometer cycling time trial without the Q-Collar, followed by a 5-kilometer cycling time trial while wearing the Q-Collar after a washout period of at least 72 hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male participants
- 18-35 years old
- Recreationally trained
- Provided written informed consent
- Achieved a maximal oxygen consumption (VO₂max) classified as "good" or "excellent" during cardiopulmonary exercise testing
Key exclusion criteria (2 listed)
- Failure to meet the required "good" or "excellent" VO₂max classification during cardiopulmonary exercise testing
- Outside age range
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 |
|---|---|---|
| Q-Collar™The Q-Collar™ is a wearable neck device that applies mild bilateral compression to the internal jugular veins. Participants wore the Q-Collar during a 5-kilometer cycling time trial. The device was individually fitted according to manufacturer guidelines and remained in place throughout the exercise trial. | Device | Control Then Q-Collar, Q-Collar Then Control |
Primary outcome
Prefrontal Cortex Oxygenation
Time frame: All throughout each 5-kilometer cycling time trial, approximately 10 minutes
Changes in prefrontal cortex oxygenated hemoglobin were continuously measured using functional near-infrared spectroscopy during 5-kilometer cycling time trials performed with and without the Q-Collar. Data were evaluated across kilometer time points.
7 secondary outcomes
Cycling Time-Trial Performance
Time frame: At completion of each 5-kilometer cycling time trial, approximately 30 seconds
Choice Reaction Time
Time frame: At baseline, 5 minutes into exercise, immediately post-exercise, and 10 minutes post-exercise during each experimental visit, approximately 2 minutes at each time point
Heart Rate
Time frame: During each 5-kilometer cycling time trial, approximately 10 minutes
Stroke Volume
Time frame: During each 5-kilometer cycling time trial, approximately 10 minutes
Cardiac Output
Time frame: During each 5-kilometer cycling time trial, approximately 10 minutes
Blood Lactate
Time frame: Immediately following each 5-kilometer cycling time trial, approximately 1 minute
Rating of Perceived Exertion
Time frame: Immediately following each 5-kilometer cycling time trial, approximately 30 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. There is no current plan for public sharing of individual participant data; however, de-identified data may be considered upon reasonable request.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q-Collar™ in people with Physiological Responses to High-Intensity Exercise, run by University of Northern Iowa 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 9 Sep 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prefrontal Cortex Oxygenation (time frame: All throughout each 5-kilometer cycling time trial, approximately 10 minutes). 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 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.