Chronic Obstructive Pulmonary DiseaseNCT05659550
Move With Air: Physiological Response Assessment
A study testing Honeywell HT-900 Turbo Force Air Circulator in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by McGill University at 1 site in Canada.
Trial summary
A fan blowing cool air to the face has been shown to alleviate breathlessness in malignant and non-malignant disease at rest and during exercise, however the underlying physiological mechanisms remain unknown. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure
- What is being tested?
- Honeywell HT-900 Turbo Force Air Circulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2023to 30 Dec 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a physician diagnosis of cardiopulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, heart failure)
- have a body mass index of >18.5 kg/m2 and <35 kg/m2
- must be cleared by a physician to perform physical activity/exercise following the completion of the 'Medical Clearance Form for Cardiopulmonary Exercise Testing'.
Who cannot join
- have changed their respiratory or cardiac medication dosage and/or frequency of administration in preceding two weeks
- have had a disease exacerbation/hospitalization in preceding six weeks
- have important contraindication(s) to exercise (e.g., significant musculoskeletal or neurological disease) or pulmonary function testing (e.g., eye, chest or stomach surgery, or any history of coughing up significant amounts of blood in the previous 3 months).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre of Innovative Medicine of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Dennis Jensen, Ph.D., 514-398-4184 ext. 0472, dennis.jensen@mcgill.ca
About this study
Official title: Move With Air: Can a Fan Reduce Exertional Breathlessness During a 4-minute Constant Rate Walking Test in Adults With Cardiopulmonary Disease?
A fan blowing cool air to the face has been shown to alleviate breathlessness in malignant and non-malignant disease at rest and during exercise, however the underlying physiological mechanisms remain unknown. This random order, three-condition design study will explore physiological mechanisms of breathlessness relief with fan-to-face therapy during constant-rate exercise in people with cardiorespiratory disease.
Read the detailed description
Constant work rate tests are viewed as the most suitable and sensitive method to assess exertional breathlessness. The 4-minute constant rate treadmill test (4-min CRTT) is a validated test wherein participants exercise at an intensity determined by an incremental test. For the purpose of this study, participants will perform three 4-min CRTT under three random-order experimental conditions: (i) fan to the face; (ii) fan to the leg; (iii) no fan. The intensity of the 4-min CRTTs will be determined based on an exercise endurance test completed in a prior visit: (i) if participants have an endurance time of <3 minutes, they will do each 4-minute CRTT at 50% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 40-50% with the speed adjusted to reach 50% PPO; (ii) if participants have an exercise endurance time of 3-8 minutes, they will do each 4-minute CRTT at 75% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 60% with the speed adjusted to reach 75% PPO; (iii) if participants have an endurance time of >8 minutes, they will do each 4-minute CRTT at 90% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 70-80% with the speed adjusted to reach 90% PPO. This model is based on a recent study on selection of exercise endurance intensities in COPD.Cardiac and dynamic respiratory parameters will be collected breath-by-breath at rest and during exercise using the Hexokin Smart Shirt. In order to target the intranasal pathway located on the trigeminal nerve that is hypothesized to modulate the mechanisms governing the potential effectiveness of a fan to the face, a metabolic cart will be omitted due to the use of the facemask or mouthpiece and nasal clip that would block this pathway.
Using the Borg 0-10 scale, rating of perceived exertion, perceptions of breathlessness intensity, unpleasantness and leg fatigue will be assessed at rest, within the last 15-seconds of each minute of exercise, and at end exercise or the symptom limited peak of exercise. Two areas of facial skin temperature, one at the forehead to target the ophthalmic branch of the trigeminal nerve and the other at the cheek to target the maxillary branch of the trigeminal nerve, will be measured prior to exercise, within the last 15-seconds of each minute of exercise, at end exercise, and following exercise using a medical grade non-contact infrared forehead thermometer. The model number of the forehead thermometer that will be used is THERMOPROPCV2 and is licensed by Health Canada and approved by the U.S. Food and Drug Administration (FDA), CE approved with European health, safety, and environmental protection standards, and approved by the Restriction of Hazardous Substances Directive (RoHS).
- Being tested
- Honeywell HT-900 Turbo Force Air Circulator
- Keywords
- Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Physiological Mechanisms, Constant work rate exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Heart Failure, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honeywell HT-900 Turbo Force Air CirculatorDevice
Also called Fan
This is a basic, portable, household fan with a single cost of CDN$21.99.
| Study group | Role | What they receive |
|---|---|---|
| Fan-to-face | Experimental | The participants will complete a 4-minute constant work rate treadmill test with a basic, portable fan placed in front of the face. The fan will be placed at a location to target the second and third branches of the trigeminal nerve and will be placed a distance chosen by the participant so that the airflow speed is comfortable. Receives: Device: Honeywell HT-900 Turbo Force Air Circulator |
| Fan-to-leg | Sham comparator | The participants will complete a 4-minute constant work rate treadmill test with a basic, portable fan placed in front of the face. The fan will be placed at a location to target the second and third branches of the trigeminal nerve and will be placed a distance chosen by the participant so that the airflow speed is comfortable. Receives: Device: Honeywell HT-900 Turbo Force Air Circulator |
| No fan | No intervention | The participants will complete a 4-minute constant work rate treadmill test with no fan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg modified 0-10 category ratio scale for breathlessness intensity
Borg modified 0-10 category ratio scale will be used to assess breathlessness intensity at end-exercise of each 4-minute constant rate treadmill test under three conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A higher score is indicative of greater breathlessness, while a lower score is indicative of lesser breathlessness.
Measured: End-exercise of the 4-minute constant rate treadmill test
Secondary outcomes (4)
Cardiopulmonary exercise test (4-minute constant rate) physiological response (ventilatory)
Mean ventilation (Liters/minute) will be compared across the 4-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A greater mean ventilation is indicative of a less efficient respiratory system, whereas a lower mean ventilation is indicative of a more efficient respiratory system.
Measured: Averaged across the 4-minute constant rate treadmill test
Cardiopulmonary exercise test (4-minute constant rate) physiological response (operating lung volumes)
Mean operating lung volumes (i.e., inspiratory capacity in liters) will be compared across the 4-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A greater operating lung volume (i.e., greater inspiratory capacity) is indicative of a better and more efficient breathing pattern, while a lower operating lung volume (i.e., smaller inspiratory capacity) is indicative of a worse and less efficient breathing pattern.
Measured: 4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
Cardiopulmonary exercise test (4-minute constant rate) physiological response (heart rate)
Mean heart rate (beats per minute) will be compared across the 4-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A lower heart rate is indicative of better cardiovascular fitness, while a higher heart rate is indicative of worse cardiovascular fitness.
Measured: Averaged across the 4-minute constant rate treadmill test
Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)
Mean oxygen saturation (in percentage) will be compared across the 4-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A lower oxygen saturation is indicative of worse health status, while a higher oxygen saturation is indicative of better health status.
Measured: Averaged across the 4-minute constant rate treadmill test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Apr 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will complete the same constant work rate exercise test under three random-order experiemental conditions.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659550
- Sponsor's protocol ID
- FanEx_2023-9286
- Status last verified
- Feb 2024
- First submitted
- 5 Dec 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move With Air: Can a Fan Reduce Exertional Breathlessness During a 4-minute Constant Rate Walking Test in Adults With Cardiopulmonary Disease?
- ClinicalTrials.gov ID
- NCT05659550
- Acronym / sponsor ID
- FanEx_2023-9286
- Keywords
- Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Physiological Mechanisms, Constant work rate exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Dec 2022 (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.
A fan blowing cool air to the face has been shown to alleviate breathlessness in malignant and non-malignant disease at rest and during exercise, however the underlying physiological mechanisms remain unknown. This random order, three-condition design study will explore physiological mechanisms of breathlessness relief with fan-to-face therapy during constant-rate exercise in people with cardiorespiratory disease.
Detailed description
Constant work rate tests are viewed as the most suitable and sensitive method to assess exertional breathlessness. The 4-minute constant rate treadmill test (4-min CRTT) is a validated test wherein participants exercise at an intensity determined by an incremental test. For the purpose of this study, participants will perform three 4-min CRTT under three random-order experimental conditions: (i) fan to the face; (ii) fan to the leg; (iii) no fan. The intensity of the 4-min CRTTs will be determined based on an exercise endurance test completed in a prior visit: (i) if participants have an endurance time of <3 minutes, they will do each 4-minute CRTT at 50% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 40-50% with the speed adjusted to reach 50% PPO; (ii) if participants have an exercise endurance time of 3-8 minutes, they will do each 4-minute CRTT at 75% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 60% with the speed adjusted to reach 75% PPO; (iii) if participants have an endurance time of >8 minutes, they will do each 4-minute CRTT at 90% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 70-80% with the speed adjusted to reach 90% PPO. This model is based on a recent study on selection of exercise endurance intensities in COPD.Cardiac and dynamic respiratory parameters will be collected breath-by-breath at rest and during exercise using the Hexokin Smart Shirt. In order to target the intranasal pathway located on the trigeminal nerve that is hypothesized to modulate the mechanisms governing the potential effectiveness of a fan to the face, a metabolic cart will be omitted due to the use of the facemask or mouthpiece and nasal clip that would block this pathway.
Using the Borg 0-10 scale, rating of perceived exertion, perceptions of breathlessness intensity, unpleasantness and leg fatigue will be assessed at rest, within the last 15-seconds of each minute of exercise, and at end exercise or the symptom limited peak of exercise. Two areas of facial skin temperature, one at the forehead to target the ophthalmic branch of the trigeminal nerve and the other at the cheek to target the maxillary branch of the trigeminal nerve, will be measured prior to exercise, within the last 15-seconds of each minute of exercise, at end exercise, and following exercise using a medical grade non-contact infrared forehead thermometer. The model number of the forehead thermometer that will be used is THERMOPROPCV2 and is licensed by Health Canada and approved by the U.S. Food and Drug Administration (FDA), CE approved with European health, safety, and environmental protection standards, and approved by the Restriction of Hazardous Substances Directive (RoHS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each participant will complete the same constant work rate exercise test under three random-order experiemental conditions.
| Arm | Type | Receives |
|---|---|---|
| Fan-to-face | Experimental | Device: Honeywell HT-900 Turbo Force Air CirculatorThe participants will complete a 4-minute constant work rate treadmill test with a basic, portable fan placed in front of the face. The fan will be placed at a location to target the second and third branches of the trigeminal nerve and will be placed a distance chosen by the participant so that the airflow speed is comfortable. |
| Fan-to-leg | Sham comparator | Device: Honeywell HT-900 Turbo Force Air CirculatorThe participants will complete a 4-minute constant work rate treadmill test with a basic, portable fan placed in front of the face. The fan will be placed at a location to target the second and third branches of the trigeminal nerve and will be placed a distance chosen by the participant so that the airflow speed is comfortable. |
| No fan | No intervention | –The participants will complete a 4-minute constant work rate treadmill test with no fan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have a physician diagnosis of cardiopulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, heart failure)
- have a body mass index of >18.5 kg/m2 and <35 kg/m2
- must be cleared by a physician to perform physical activity/exercise following the completion of the 'Medical Clearance Form for Cardiopulmonary Exercise Testing'.
Key exclusion criteria (3 listed)
- have changed their respiratory or cardiac medication dosage and/or frequency of administration in preceding two weeks
- have had a disease exacerbation/hospitalization in preceding six weeks
- have important contraindication(s) to exercise (e.g., significant musculoskeletal or neurological disease) or pulmonary function testing (e.g., eye, chest or stomach surgery, or any history of coughing up significant amounts of blood in the previous 3 months).
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 |
|---|---|---|
| Honeywell HT-900 Turbo Force Air CirculatorAlso: FanThis is a basic, portable, household fan with a single cost of CDN$21.99. | Device | Fan-to-face, Fan-to-leg |
Primary outcome
Borg modified 0-10 category ratio scale for breathlessness intensity
Time frame: End-exercise of the 4-minute constant rate treadmill test
Borg modified 0-10 category ratio scale will be used to assess breathlessness intensity at end-exercise of each 4-minute constant rate treadmill test under three conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A higher score is indicative of greater breathlessness, while a lower score is indicative of lesser breathlessness.
4 secondary outcomes
Cardiopulmonary exercise test (4-minute constant rate) physiological response (ventilatory)
Time frame: Averaged across the 4-minute constant rate treadmill test
Cardiopulmonary exercise test (4-minute constant rate) physiological response (operating lung volumes)
Time frame: 4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
Cardiopulmonary exercise test (4-minute constant rate) physiological response (heart rate)
Time frame: Averaged across the 4-minute constant rate treadmill test
Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)
Time frame: Averaged across the 4-minute constant rate treadmill test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Link to Dr. Dennis Jensen's Clinical Exercise and Respiratory Physiology Laboratory pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dennis Jensen, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honeywell HT-900 Turbo Force Air Circulator in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by McGill University at 1 site in Canada.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachelle I Aucoin, PhD Student (514-398-4184 ext. 09081, rachelle.aucoin@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg modified 0-10 category ratio scale for breathlessness intensity (time frame: End-exercise of the 4-minute constant rate treadmill test). 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 15 Feb 2024.