Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction (NCT05558020) | Clinical Trial Compass
UnknownNot Applicable
Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
Denmark10 participantsStarted 2022-12-05
Plain-language summary
TITLE Feasibility of constant work rate testing to detect exercise-induced laryngeal obstruction
DESIGN Prospective observational pilot study
AIMS To investigate if constant work rate testing at different work rates will sufficiently induce detectable exercise-induced laryngeal obstruction (EILO) using CLE.
POPULATION Adult patients with EILO
DURATION 01.09.2022 - 30.06.2023
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 or above with a clinical suspicion of having EILO.
* Individuals with concurrent asthma can participate in the study provided that their asthma is well-controlled, determined by a negative bronchoprovocation test.
Exclusion Criteria:
* No EILO found in Clinical standard-of-care CLE test
* Not able to complete the exercise test for other reasons than breathlessness or leg fatigue (e.g. injury, disease or disability preventing cycling to maximal exertion).
* Comorbidities other than asthma, which, judged by the investigator, might confound the test results or pose a medical risk to the patient (e.g. cardiac disease, exercise-induced anaphylaxis).
* Current smokers (\< 6 months of stopping) or individuals with a significant smoking history (\>10 pack years).
* Pregnancy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
prevalence and degree of glottic or supraglottic collapse in EILO patients
Timeframe: Changes from baseline during the procedure and immediately after cessation of the exercise test.
2
Time of onset of the laryngeal obstruction
Timeframe: A time of onset determined during the procedures
3
Observed duration of the laryngeal obstruction
Timeframe: Duration measured in seconds during the procedures