Treatment for exercise-induced laryngeal obstruction
Exercise Induced Laryngeal Obstruction; a Randomized Controlled Treatment Trial
This study is testing different treatment options for young people with exercise-induced breathing problems to see which ones help them breathe better during physical activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT04620343 on ClinicalTrials.gov |
What this trial studies
This study investigates treatment options for exercise-induced laryngeal obstruction (EILO), a condition that causes breathing difficulties during physical activity in young individuals. Patients diagnosed with EILO will be randomized into four treatment groups, each receiving different combinations of breathing advice, inspiratory muscle training, and speech therapy. The goal is to provide evidence-based information on effective interventions for EILO, which has not been thoroughly validated through randomized controlled trials. The study will be conducted at Haukeland University Hospital, where patients will undergo continuous laryngeal visualization during high-intensity exercise to assess their condition.
Who should consider this trial
Good fit: Ideal candidates are young individuals diagnosed with EILO who experience significant respiratory complaints and are seeking treatment.
Not a fit: Patients with breathing problems caused by conditions other than EILO or those with well-controlled asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for young patients suffering from EILO, improving their exercise tolerance and quality of life.
How similar studies have performed: While there is empirical data suggesting positive responses to treatment for EILO, this study aims to fill the gap in randomized controlled trials, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * EILO with CLE score at peak exercise graded as ≥ 2 at glottic or supraglottic level and * Respiratory complaints to an extent that the patient wants further treatment and follow-up. Exclusion Criteria: * Breathing problems caused by disorders other than EILO or well controlled asthma. * Perceived to be unable to perform repeated maximal cardiopulmonary treadmill exercise tests, or failing to accept the procedures required for repeated successful CLE tests, or unable to perform any of the other examinations required by the protocol. * Abnormal anatomy at rest in the laryngeal region or the upper airways. * Age below 12 years
Where this trial is running
Bergen, Vestland
- Haukeland University Hospital, Children and Youth Clinic — Bergen, Vestland, Norway (Recruiting)
Study contacts
- Principal investigator: Hege H Clemm, MD, PhD — Haukeland University Hospital
- Study coordinator: Hege H Clemm, MD, PhD
- Email: hege.synnove.havstad.clemm@helse-bergen.no
- Phone: 004792606661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.