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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
Summary
This trial will explore how fan-to-face therapy helps with breathlessness during exercise in people with cardiorespiratory disease.
Who is the study for?
This trial is for people who feel breathless during exercise despite treatment, with a BMI between 18.5 and 35, cleared for physical activity by a doctor, and diagnosed with cardiopulmonary diseases like COPD or heart failure. It's not for those who've changed medication recently or had an exacerbation/hospitalization in the last six weeks.
What is being tested?
The study tests if blowing cool air on the face using Honeywell HT-900 Turbo Force Air Circulator can relieve shortness of breath during constant-rate exercise in individuals with cardiorespiratory disease. The aim is to understand how this simple intervention works physiologically.
What are the potential side effects?
Since the intervention involves non-invasive use of a fan to circulate air, there are no direct medicinal side effects expected from this trial. However, participants should be monitored for any discomfort or adverse reactions related to airflow exposure during exercise.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Borg modified 0-10 category ratio scale for breathlessness intensity
Secondary study objectives
Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)
Cardiopulmonary exercise test (4-minute constant rate) physiological response (heart rate)
Cardiopulmonary exercise test (4-minute constant rate) physiological response (operating lung volumes)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Fan-to-faceExperimental Treatment1 Intervention
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.
Group II: No fanActive Control1 Intervention
The participants will complete a 4-minute constant work rate treadmill test with no fan.
Group III: Fan-to-legPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
McGill UniversityLead Sponsor
411 Previous Clinical Trials
1,018,475 Total Patients Enrolled
Dennis Jensen, PhDPrincipal InvestigatorMcGill University
2 Previous Clinical Trials
88 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was hospitalized due to my condition worsening in the last six weeks.I cannot exercise or have certain tests due to health issues like recent surgery or coughing up blood.I have been cleared by a doctor to do physical activities.I have been diagnosed with a heart or lung condition.I have not changed my heart or lung medication in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: No fan
- Group 2: Fan-to-face
- Group 3: Fan-to-leg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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