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HelpILO - RCT on EILO Treatment

Exercise Induced Laryngeal Obstruction; a Randomized Controlled Treatment Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04620343
Enrollment
350
Registered
2020-11-09
Start date
2021-01-01
Completion date
2036-12-31
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Induced Laryngeal Obstruction (EILO)

Keywords

Larynx, Obstruction, Exercise

Brief summary

Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise.

Detailed description

Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise. Studies indicate that EILO responds positively to treatment interventions; however, the investigators lack randomized controlled studies to confirm this (10-15). This study aims to provide evidence-based information on interventions commonly applied to treat EILO. Background: Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise. Empirical data suggest that EILO consists of different subtypes that require different therapeutic approaches. However, currently applied treatment schemes do not rest on randomized controlled trials. This study aims to provide evidence-based information on treatment schemes commonly applied in patients with EILO. Methods: Consenting patients consecutively diagnosed with EILO at Haukeland University Hospital will be randomized into four different conservative treatment arms, selected on the basis of promising reports from non-randomized studies: (A) standardized information and breathing advice only (IBA), (B) IBA plus inspiratory muscle training, (C) IBA plus speech therapy, and (D) IBA plus provision of both inspiratory muscle training and speech therapy. Differential effects in predefined EILO subtypes will be addressed. Patients failing the conservative approach and otherwise qualifying for surgical treatment by current department policy will be considered for randomization into (E) standard or (F) minimal laser supraglottoplasty, and a wait-and-see control group. Power calculations will be based on the main outcomes, laryngeal adduction during peak exercise, rated by a validated scoring system before and after the interventions. Discussion: The study will provide evidence-based information on the treatment of EILO, listed as a priority in a recent statement issued by the European Respiratory Society, requested by clinicians and researchers engaged in this area, and relevant to 5-7% of young people.

Interventions

PROCEDUREA: Breathing advice with bio-feedback

Information and breathing advice with biofeedback will serve as an active comparator in this study, and time allowed for IBA and biofeedback in this study will be max 30 min. The teaching will be provided by the attending physician and the test leader. The session will follow a strict checklist. After the laryngoscope has been secured in correct position the patient will be shown his/her larynx on the screen, providing the patient with basic knowledge on laryngeal anatomy and function in a calm atmosphere before the CLE-test. After, the patients will be trained to make any symptoms abate, and a good breathing posture and how to optimally use their breathing muscles.

PROCEDUREB: Breathing advice with bio-feedback, Inspiratory muscle training (IMT)

Breathing advise and IMT. The inspiratory muscle training (IMT) will build on the information the patients have obtained during the IBA and biofeedback session. The IMT will focus on training endurance and coordination of the PCA muscle, aiming to reduce fatigue of the abducting capacity of the larynx and to enhance coordination and create a sense of laryngeal control. When performing the IMT sessions, it is of utmost importance that a functional diaphragmatic breathing pattern has been established, and that this breathing pattern is maintained throughout all the IMT sessions. Once the patient has demonstrated that he/she is able to perform breathing according to these principles, the IMT session will follow a detailed protocol while wearing a flexible laryngoscope and settings and techniques are adjusted to ensure max open larynx. The patient will perform IMT training at home as instructed and have video meetings one and three weeks after initial training to observe progress.

PROCEDUREC: Breathing advice with bio-feedback, Speech Therapy

The training period with the speech therapist takes three days, divided into 6 sessions. The training is continued at home, implementing the techniques during physical activity and at rest. The aim of the speech therapy is to help the patients to develop a strategy on how to control his/her larynx during exercise, and to be able to continue exercising without experiencing dramatic EILO incidents. They will be informed that the best approach is to start practicing while performing low to moderate intensity exercise, and then gradually increase the intensity as they become more confident. It will be emphasized that the new breathing technique they are about to adopt will need to be repeated until it becomes adapted as a part of their automated breathing pattern. Patients will be followed up with video meetings one and three weeks after initial training to observe progress.

PROCEDURED: Breathing advice with bio-feedback, IMT and Speech Therapy

All treatments as described above.

PROCEDUREA: If CLE-test unchanged, additional IMT and Speech Therapy

All treatments as described above.

PROCEDURESurgery 1: Supraglottoplasty - full procedure under general anesthesia

Endoscopic supraglottoplasty with carbon dioxide laser and cold steel microlaryngeal instruments. The patient is intubated with an armored laser-tube which is positioned in the posterior midline to protect this area from laser injury. The laryngoscope is positioned into the vallecula and the surgery is visualized through an operation-microscope. CO2-laser beams of 2-4W focused with micro spot is utilized. Releasing incisions are made at the anterior border of both AEFs. The depth of the incisions are limited to the cranial border of the ventricular folds. The cuneiform tubercles including their surrounding mucosa are removed in a circular pattern before the two incisions are adjoined, thus creating a drop shaped excision. Care is taken to avoid scarring. It is recommended to protect the posterior commissure and the piriform sinus with wet tissue cloths. In case of perioperative edema of the laryngeal mucosa, corticosteroids are administrated to prevent laryngeal edema post-operatively.

PROCEDURESurgery 2: Supraglottoplasty - mini-invasive procedure under general anesthesia

Endoscopic supraglottoplasty with carbon dioxide laser. The patients are intubated with an armored laser-tube, which is positioned in the posterior midline to protect this area from laser injury. The laryngoscope (Benjamin/Lindholm) is positioned into the vallecula and the surgery is visualized through an operation-microscope. CO2-laser beams of 2-4W focused with micro spot are utilized. Four punctures will be made along the lateral borders of both aryepiglottic folds bilateral, thus creating a row of small punctures parallel to the rim of the aryepiglottic folds. The punctions should not be deeper than the incision in the full procedure (above); i.e. less than 5 millimeter, and care must be taken to avoid heat affecting the nervus recurrens posteriorly. Care is taken to avoid scarring and collateral thermal injury. It is recommended to protect the posterior commissure and the piriform sinus with wet tissue cloths. No antibiotic prophylaxis is administered.

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
QuestionnairesDay 1All patients will complete custom-made questionnaires recording demographic background variables and symptom scores. The questionnaires focus mainly on respiratory symptoms experienced by the patients, treatment they have been exposed to, and diagnoses they have been assigned. Relevant co-morbidities will also be recorded.
Pulmonary function and exercise test - Spirometry 1Through study completion, on average 6 monthsRecording of expiratory and inspiratory volumes and flows will be recorded: Forced expiratory and inspiratory volume capacity (FVC and FIVC). Volumes measured in liters
Pulmonary function and exercise test - Spirometry 2Through study completion, on average 6 monthsRecording of expiratory and inspiratory volumes and flows will be recorded: forced expiratory and inspiratory volume in first second (FEV1 and FIV1). Volumes measured in liters
Pulmonary function and exercise test - Spirometry 3Through study completion, on average 6 monthsRecording of expiratory and inspiratory volumes and flows will be recorded: forced expiratory and inspiratory flow at 50% of FVC (FEF and FIF50) and at 25-75% of FVC (FEF and FIF25-75). Volumes measured in liters.
Continuous Laryngoscopy Exercise test (CLE-test) and scoringThrough study completion, on average 6 monthsCLE-scores from the video recordings from the CLE-test will be evaluated. Two highly experienced raters will score all CLE tests according to a system that has been published previously. CLE scoring of glottic and supraglottic obstruction, grades 0 to 4.
Cardiopulmonary exercise (CPX) data - Variables of gas exchangeThrough study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of gas exchange are measured breath-by-breath. Oxygen absorption measured in mL(min)/kg. Co2 production and O2 production in mL/min.
Cardiopulmonary exercise (CPX) data - duration of runThrough study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Duration of run is recorded in minutes and seconds.
Cardiopulmonary exercise (CPX) data - distance of runThrough study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Distance of run is recorded in meters
Cardiopulmonary exercise (CPX) data - oxygen consumptionThrough study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of oxygen consumption will be recorded. Oxygen consumption is measured in (mL/min)/kg
Cardiopulmonary exercise (CPX) data - CO2 productionThrough study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of CO2 production will be recorded in mL/minute.
Cardiopulmonary exercise (CPX) data - respiratory rates.Through study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of respiratory and tidal volumes will be recorded in liters and ratios calculated.
Cardiopulmonary exercise (CPX) data - heart rates.Through study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of heart rates will be recorded in Hf/min.
Cardiopulmonary exercise (CPX) data - Exercise tidal flow/volume loopsThrough study completion, on average 6 monthsA treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Exercise tidal flow/volume loops will be obtained at fixed interval during the session by plotting air flow (l/sec) and air volume the patient breathes during testing.
Continuous laryngoscopy exercise (CLE) with pressure recordingsDuring Phase 3, average duration 6 months.Translaryngeal resistance will be measured during CLE-testing in the third phase. Calculation of resistance will be based on pressure recordings obtained by two pressure sensors placed above and below the larynx, and airflow measured breath by breath by the mouth. Pressure is measured in kPa.

Countries

Norway

Contacts

Primary ContactHege H Clemm, MD, PhD
hege.synnove.havstad.clemm@helse-bergen.no004792606661
Backup ContactThomas Halvorsen, MD, PhD
thomas.halvorsen@helse-bergen.no004792464843

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026