HelpILO - RCT on EILO Treatment

Haukeland University Hospital

Status

Enrolling

Conditions

Exercise Induced Laryngeal Obstruction (EILO)

Treatments

Procedure: C: Breathing advice with bio-feedback, Speech Therapy

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

Procedure: Surgery 1: Supraglottoplasty - full procedure under general anesthesia

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

Procedure: A: Breathing advice with bio-feedback

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

Procedure: Surgery 2: Supraglottoplasty - mini-invasive procedure under general anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04620343

2020/134444

Details and patient eligibility

About

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.

Full description

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.

Enrollment

350 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

350 participants in 9 patient groups

Phase 1, Group 1

Active Comparator group

Description:

Patients are provided with basic information and breathing advice with biofeedback (IBA). This is the reference treatment against which the other methods will be measured.

Treatment:

Procedure: A: Breathing advice with bio-feedback

Phase 1, Group 2

Experimental group

Description:

Patients are provided with basic information and breathing advice with biofeedback (IBA) and treated with inspiratory muscle training (IMT)

Treatment:

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

Phase 1, Group 3

Experimental group

Description:

Patients are provided with basic information and breathing advice with biofeedback (IBA) and treated with speech therapy

Treatment:

Procedure: C: Breathing advice with bio-feedback, Speech Therapy

Phase 1, Group 4

Experimental group

Description:

Patients are provided with basic information and breathing advice with biofeedback (IBA) and treated with inspiratory muscle training (IMT) and speech therapy

Treatment:

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

Phase 2, Group 1

No Intervention group

Description:

Groups 2,3,4 in Phase 1 Wait for therapy effect

Phase 2, Group 2

Experimental group

Description:

If patients from Phase 1, Group 1 (reference treatment) have unchanged CLE-scoring, they are treated with inspiratory muscle training (IMT) and speech therapy.

Treatment:

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

Phase 3, Group 1

Experimental group

Description:

Treated with Surgery, supraglottoplasty - full procedure

Treatment:

Procedure: Surgery 1: Supraglottoplasty - full procedure under general anesthesia

Phase 3, Group 2

Experimental group

Description:

Treated with Surgery, supraglottoplasty mini-invasive procedure