Exercise-induced LaryngomalaciaEILNCT00520624
Treatment of Exercise-induced Laryngomalacia in Elite Athletes
A study testing inspiratory muscle strength training and Surgery in people with Exercise-induced Laryngomalacia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical activity) in elite athletes using two different treatments. The study is randomized with control groups. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Exercise-induced Laryngomalacia
- What is being tested?
- inspiratory muscle strength training and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jan 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laryngoscopically verified EIL,
- Elite athlete for a minimum of 1 year and continuing for a minimum 6 months after start of treatment
Who cannot join
- Has to be able to run on treadmill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes
Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical activity) in elite athletes using two different treatments. The study is randomized with control groups.
- Conditions
- Exercise-induced Laryngomalacia
- Being tested
- inspiratory muscle strength training, Surgery
- Keywords
- EIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle strength trainingDevice
SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment 1, for those with high degree of EIL Receives: Device: inspiratory muscle strength training |
| 2 | Experimental | Treatment 2, for those with high degree of EIL Receives: Procedure: Surgery |
| 3 | No intervention | Control group of those with high degree of EIL |
| 4 | Experimental | Treatment 1, for those with low degree of EIL Receives: Device: inspiratory muscle strength training |
| 5 | No intervention | Control group of those with low degree of EIL |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startJan 2013
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: No patients willing to join
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced LaryngomalaciaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Vibeke Backer, Bispebjerg Hospital
- Investigators
- Vibeke Backer, Study director, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520624
- Sponsor's protocol ID
- PC-EIL-07-ELITE
- Acronym
- EIL
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2007
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes
- ClinicalTrials.gov ID
- NCT00520624
- Acronym / sponsor ID
- EIL / PC-EIL-07-ELITE
- Conditions
- Exercise-induced Laryngomalacia
- Keywords
- EIL
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients willing to join
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 24 Aug 2007 (estimated)
- 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.
Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical activity) in elite athletes using two different treatments. The study is randomized with control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: inspiratory muscle strength trainingTreatment 1, for those with high degree of EIL |
| 2 | Experimental | Procedure: SurgeryTreatment 2, for those with high degree of EIL |
| 3 | No intervention | –Control group of those with high degree of EIL |
| 4 | Experimental | Device: inspiratory muscle strength trainingTreatment 1, for those with low degree of EIL |
| 5 | No intervention | –Control group of those with low degree of EIL |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Laryngoscopically verified EIL,
- Elite athlete for a minimum of 1 year and continuing for a minimum 6 months after start of treatment
Key exclusion criteria (1 listed)
- Has to be able to run on treadmill
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 |
|---|---|---|
| inspiratory muscle strength training | Device | 1, 4 |
| Surgery | Procedure or surgery | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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.
Vibeke Backer study director
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle strength training and Surgery in people with Exercise-induced Laryngomalacia, 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Jan 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 28 Jan 2021.