Balloon dilation procedure for treating Eustachian tube dysfunction

Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction: a Randomized, Sham-controlled Trial

This study is testing if a balloon dilation procedure can help people with Eustachian tube dysfunction feel better compared to a fake treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Calgary (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Calgary, Alberta and 1 other locations)
• Trial ID: NCT05719207 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of balloon dilation of the eustachian tube in patients suffering from eustachian tube dilatory dysfunction (ETDD). Participants will be randomly assigned to receive either the balloon dilation procedure or a sham procedure to assess the treatment's superiority. The study aims to identify patient characteristics that correlate with positive outcomes and to confirm the safety of the balloon dilation technique. This research addresses a significant gap in effective treatments for ETDD, which currently lacks reliable medical options.

Who should consider this trial

Good fit: Ideal candidates include adults with chronic ETDD or baro-challenge ETDD who have not responded to conservative treatments.

Not a fit: Patients with patulous eustachian tube dysfunction or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could provide a new, effective treatment option for patients suffering from Eustachian tube dysfunction.

How similar studies have performed: Previous studies have shown promising results for balloon dilation of the eustachian tube, but this study aims to provide more rigorous evidence through a placebo-controlled design.

Eligibility criteria

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.

Where this trial is running

Calgary, Alberta and 1 other locations

• Otology Clinic, Clinic 7A, South Health Campus — Calgary, Alberta, Canada (RECRUITING)
• Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Justin Lui, MD, FRCSC — University of Calgary
• Study coordinator: Jaimi Workun

Conditions: Eustachian Tube Dysfunction, Barotitis, BDET, ETD, ETDD, baro-challenge