Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

NCT05719207 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Calgary

Phase

Not applicable

Started

2023-06-25

Last updated

2025-04-03

Condition(s) studied

Eustachian Tube DysfunctionBarotitis

Investigational drug(s) / intervention(s)

Balloon dilation of eustachian tubeSham procedure

Balloon dilation of eustachian tube: Patients in the intervention group would undergo balloon dilation of the eustachian tube under local anesthetic in clinic. The Stryker XprESS LoProfile ENT dilation system or the Stryker Audion ET dilation system will be used.

Sham procedure: Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.

Study summary

This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. The investigators are carrying out this research study with the following goals:

1. Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction
2. Identify patient variables associated with positive response to balloon dilation of the eustachian tube
3. Re-demonstrate the safety of balloon dilation of the eustachian tube

What does participation in this study involve? Participants in this study will:

* Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks later
* Agree to allowing the investigators access to their personal health information
* Complete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure:

* A questionnaire to assess your eustachian tube dysfunction
* An assessment of the movement of your ear drum (tympanogram)
* A hearing test (audiogram)
* A questionnaire to assess the impact of eustachian tube dysfunction on work/activity
* A questionnaire to assess overall health-related quality of life
* An assessment of the ability to equalize middle ear pressure(s)
* Visual examination of the ear drums
* Repeat the above assessments and questionnaires over the course of four follow-up appointments at 6-, 24-, and 52-weeks after the procedure.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria (Chronic ETDD): * \>3 months of symptoms of ETDD (otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged) persistent at enrollment * Persistence of symptoms despite \>4 weeks INCS or \>7d course of systemic steroid within 6 months from enrollment * Documented Type B or C tympanogram at or within 6 months from enrollment * ETDQ7 ≥ 2.1 at enrollment Inclusion criteria (baro-challenge ETDD): * \>12 months of baro-challenge induced symptoms occurring at least every 4 months within the past year * Symptoms include otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged, vertigo, or facial nerve palsy, which resolve within 3 days of pressure equalization. * Failure of at least one of: topical/oral decongestant, pneumatization device, and/or pressure relief ear plugs. Exclusion Criteria: * Signs/symptoms of patulous eustachian tube dysfunction (autophony, tympanic membrane movement with breathing) * Adjunctive surgical procedure needed (ex. septoplasty, tympanostomy tube) * Presence of a tympanic membrane (TM) perforation or tympanostomy tube * Fluctuating SNHL, AOM, grade IV TM retraction, or tympanosclerosis of \>50% of the TM * Uncontrolled sino-nasal disease, reflux, TMJ disorder, immunodeficiency, or allergies * Known ICA dehiscence of the bony ET of the symptomatic ear * Recent head and neck surgery within the past 3 months or planned procedure during study * History of radiation to the head and neck * History of craniofacial abnormality * Prior ET intervention * Psychiatric condition or cognitive impairment which precludes capacity to consent.

Primary outcome measure(s)

Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score — 6 weeks, 24 weeks, and 52 weeks post-intervention
Score range 1-7, with higher score indicating more severe symptoms
Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire) — 6 weeks, 24 weeks, and 52 weeks post-intervention
Composite of quantitative and qualitative data points

Trial sites (2)

Facility	City	Region	Status
Otology Clinic, Clinic 7A, South Health Campus	Calgary	Alberta	Recruiting
Sunnybrook Health Sciences Center	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05719207 on ClinicalTrials.gov ↗ ← All trials in Canada