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

Launched by UNIVERSITY OF CALGARY · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called balloon dilation of the eustachian tube, which may help people who have eustachian tube dysfunction—a condition that can cause symptoms like ear pressure, muffled hearing, and discomfort. Traditionally, doctors have treated this condition with nasal sprays or by placing tubes in the ears, but these methods don’t always work and can have risks. The goal of the trial is to see if balloon dilation is more effective than a placebo (a fake procedure) and to find out who benefits most from this treatment, while also reviewing the safety of the procedure.

To participate in the study, you should have had symptoms of eustachian tube dysfunction for at least three months, with no improvement from other treatments. You will be randomly assigned to either the balloon dilation procedure or the placebo and will have the option to receive the actual treatment six weeks later. Participants will undergo several assessments before and after the procedure, including questionnaires about your symptoms and quality of life, as well as tests to check your hearing and ear drum function. If you’re interested and meet the eligibility requirements, this trial could offer you a new option for managing your ear discomfort.

Gender

ALL

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.