Exercise-induced Laryngeal Obstruction (EILO)NCT05558020
Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
An observational study of Exercise-induced Laryngeal Obstruction (EILO), run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise-induced Laryngeal Obstruction (EILO)
- What is being tested?
- Continuous laryngoscopy during exercise (CLE), incremental exercise protocol and Continuous laryngoscopy during exercise (CLE), continuous work rate protocol
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Dec 2022to Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
København NV, Capital Region, 2400
Emil Ingerslev Walsted, MD, PhD, +4530338750, emil.ingerslev.walsted@regionh.dk
Jens Thougaard Pedersen, B.Sc, +4529422843, jens.thougaard.pedersen@regionh.dk
About this study
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
- Being tested
- Continuous laryngoscopy during exercise (CLE), incremental exercise protocol, Continuous laryngoscopy during exercise (CLE), continuous work rate protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous laryngoscopy during exercise (CLE), incremental exercise protocolDiagnostic test
The incremental work rate exercise test will be performed using a cycle-ergometer. The exercise protocol is initiated by a five-minute warm-up at 50 Watts (W). Subsequently, they will complete a stepwise protocol, which will begin at 100 W and increase by 2 W every 6th second, until exhaustion or until the patient is unable to continue exercise, for any reason.
Continuous laryngoscopy during exercise (CLE), continuous work rate protocolDiagnostic test
Within two weeks the participants will perform an additional CLE-test at various intensities. The new exercise protocol is designed to induce EILO at different exercise intensities. Using the participants' individually calculated exercise capacity, three different workloads (70 %, 80 % and 90 %) will be calculated.
The exercise protocol will be initiated with a five-minute warm-up at 50 W, then the workload will increase to the watt equivalent to 70 % of the participant's maximal exercise capacity. This workload will be fixed for ten minutes and only terminated if the participant feels the need to stop due to exhaustion or breathing difficulties. Next, the participant will have a five-minute resting phase with a set workload of 50 W. This protocol will be repeated at a workload equivalent to 80 % and 90 %
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and degree of glottic or supraglottic collapse in EILO patients
Laryngoscopic detection of supraglottic or a glottic obstruction of the same severity as observed during incremental testing, during a submaximal constant work rate exercise test (70 %, 80 % and 90 %) using a visual grade scale (0-3, with 0 reflecting no obstruction, and 3 being the most severe degree of obstruction).
Measured: Changes from baseline during the procedure and immediately after cessation of the exercise test.
Time of onset of the laryngeal obstruction
A specific point in time where observed laryngeal obstruction is first discernible will be determined during the evaluation of the laryngoscopic videos.
This is to descriptively quantify this outcome.
Measured: A time of onset determined during the procedures
Observed duration of the laryngeal obstruction
The investigators will further evaluate the laryngoscopic videos and determine the duration of the participant's laryngeal obstruction. This duration is defined as the time period from the time of onset during submaximal exercise, until remission of the observed obstruction or end of the test.
Measured: Duration measured in seconds during the procedures
Secondary outcomes (7)
Patient reported symptom score: Dyspnoea-12
The patients will fill out the Dyspnoea-12 questionnaire before the first exercise test The questionnaire consists of 12 questions regarding dyspnoea. This is a descriptive measure
Measured: At baseline
Patient reported symptom scores: Nijmegen
The participants will fill out the Nijmegen questionnaire before the first exercise test The questionnaire consists of 16 questions, with answers ranging from "never" to "very often". A score is calculated from these answers. A higher score means that it is more likely that the participant suffers from hyperventilation syndrome.
This is a descriptive measure
Measured: At baseline
Patient reported symptom scores: Multidimensional Dyspnoea Profile (MDP).
The patients will fill out the Multidimensional Dyspnoea Profile (MDP) questionnaire before the first exercise test This profile consists of questions regarding both affective and sensory components of dyspnoea.
This is a descriptive measure
Measured: At baseline
Modified borg dyspnoea during exercise
Minimum score: 0 Maximum score: 10 The participant will be asked to rate dyspnoea at baseline and during the CLE tests at 1 minute intervals.
The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.
Measured: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Leg fatigue scores during exercise
Minimum score: 0 Maximum score: 10 The participant will be asked to rate leg fatigue at baseline and during the CLE tests at 1 minute intervals.
The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.
Measured: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Rate of perceived exertion (RPE) scores during exercise
Minimum score: 0 Maximum score: 10 The participant will be asked to evaluate their rate of perceived exertion at baseline and during the CLE tests at 1 minute intervals.
The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.
Measured: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Inter-rater agreement of the prevalence and degree of glottic or supraglottic collapse in EILO patients
After obtaining laryngoscopic video data, the investigators will evaluate the severity of laryngeal obstruction using a visual grade scale (0-3).
From these gradings we will calculate inter-rater agreement values (weighted kappa).
Measured: During data analysis (month 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start5 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced Laryngeal Obstruction (EILO)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Walsted, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558020
- Sponsor's protocol ID
- H-20057391
- Status last verified
- Aug 2023
- First submitted
- 15 Sep 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thougaard J, Pedersen L, Walsted E. Feasibility of Constant Work Rate Testing to Detect Exercise-Induced Laryngeal Obstruction. Med Sci Sports Exerc. 2024 Mar 1;56(3):427-434. doi: 10.1249/MSS.0000000000003319. Epub 2023 Oct 12.
PubMed 38356163
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
- ClinicalTrials.gov ID
- NCT05558020
- Acronym / sponsor ID
- H-20057391
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Sep 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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Continuous laryngoscopy during exercise (CLE), incremental exercise protocolThe incremental work rate exercise test will be performed using a cycle-ergometer. The exercise protocol is initiated by a five-minute warm-up at 50 Watts (W). Subsequently, they will complete a stepwise protocol, which will begin at 100 W and increase by 2 W every 6th second, until exhaustion or until the patient is unable to continue exercise, for any reason. | Diagnostic test | – |
| Continuous laryngoscopy during exercise (CLE), continuous work rate protocolWithin two weeks the participants will perform an additional CLE-test at various intensities. The new exercise protocol is designed to induce EILO at different exercise intensities. Using the participants' individually calculated exercise capacity, three different workloads (70 %, 80 % and 90 %) will be calculated. The exercise protocol will be initiated with a five-minute warm-up at 50 W, then the workload will increase to the watt equivalent to 70 % of the participant's maximal exercise capacity. This workload will be fixed for ten minutes and only terminated if the participant feels the need to stop due to exhaustion or breathing difficulties. Next, the participant will have a five-minute resting phase with a set workload of 50 W. This protocol will be repeated at a workload equivalent to 80 % and 90 % | Diagnostic test | – |
Primary outcome
prevalence and degree of glottic or supraglottic collapse in EILO patients
Time frame: Changes from baseline during the procedure and immediately after cessation of the exercise test.
Laryngoscopic detection of supraglottic or a glottic obstruction of the same severity as observed during incremental testing, during a submaximal constant work rate exercise test (70 %, 80 % and 90 %) using a visual grade scale (0-3, with 0 reflecting no obstruction, and 3 being the most severe degree of obstruction).
Time of onset of the laryngeal obstruction
Time frame: A time of onset determined during the procedures
A specific point in time where observed laryngeal obstruction is first discernible will be determined during the evaluation of the laryngoscopic videos. This is to descriptively quantify this outcome.
Observed duration of the laryngeal obstruction
Time frame: Duration measured in seconds during the procedures
The investigators will further evaluate the laryngoscopic videos and determine the duration of the participant's laryngeal obstruction. This duration is defined as the time period from the time of onset during submaximal exercise, until remission of the observed obstruction or end of the test.
7 secondary outcomes
Patient reported symptom score: Dyspnoea-12
Time frame: At baseline
Patient reported symptom scores: Nijmegen
Time frame: At baseline
Patient reported symptom scores: Multidimensional Dyspnoea Profile (MDP).
Time frame: At baseline
Modified borg dyspnoea during exercise
Time frame: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Leg fatigue scores during exercise
Time frame: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Rate of perceived exertion (RPE) scores during exercise
Time frame: At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Inter-rater agreement of the prevalence and degree of glottic or supraglottic collapse in EILO patients
Time frame: During data analysis (month 1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 38356163Thougaard J, Pedersen L, Walsted E. Feasibility of Constant Work Rate Testing to Detect Exercise-Induced Laryngeal Obstruction. Med Sci Sports Exerc. 2024 Mar 1;56(3):427-434. doi: 10.1249/MSS.0000000000003319. Epub 2023 Oct 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise-induced Laryngeal Obstruction (EILO), run by Bispebjerg Hospital at 1 site in Denmark.
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 5 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 16 Aug 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emil Walsted, MD, PhD (+4530338750, emil.ingerslev.walsted@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and degree of glottic or supraglottic collapse in EILO patients (time frame: Changes from baseline during the procedure and immediately after cessation of the exercise test.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558020, which also lists 1 linked publication.
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 16 Aug 2023.