Clinical trial NCT05558020: Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
Official title: Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exercise-induced Laryngeal Obstruction (EILO)
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals referred to CLE testing at the asthma service at Bispebjerg Hospital in Copenhagen, Denmark, for the investigation of exercise-related respiratory symptoms, will be offered to participate in the present study in addition to the standard-of-care incremental CLE test.

Al patients will be evaluated during the visit to the asthma service at Bispebjerg Hospital to ensure they are clinically fit for exercise testing.

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
measure: Time of onset of the laryngeal obstruction
timeFrame: A time of onset determined during the procedures
measure: Observed duration of the laryngeal obstruction
timeFrame: Duration measured in seconds during the procedures
Secondary outcomes:
measure: Patient reported symptom score: Dyspnoea-12
timeFrame: At baseline
measure: Patient reported symptom scores: Nijmegen
timeFrame: At baseline
measure: Patient reported symptom scores: Multidimensional Dyspnoea Profile (MDP).
timeFrame: At baseline
measure: Modified borg dyspnoea during exercise
timeFrame: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
measure: Leg fatigue scores during exercise
timeFrame: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
measure: Rate of perceived exertion (RPE) scores during exercise
timeFrame: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
measure: Inter-rater agreement of the prevalence and degree of glottic or supraglottic collapse in EILO patients
timeFrame: During data analysis (month 1).
Other outcomes:
Locations:
city: København NV
country: Denmark
facility: Bispebjerg Hospital
state: Region Hovedstaden
Study officials:
References: