RecruitingNot Applicable

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

Canada76 participantsStarted 2023-06-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score

Timeframe: 6 weeks, 24 weeks, and 52 weeks post-intervention

Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)

Timeframe: 6 weeks, 24 weeks, and 52 weeks post-intervention

Trial details

NCT IDNCT05719207

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Jaimi Workun

403-764-4755 jaimi.workun@albertahealthservices.ca

View on ClinicalTrials.gov More Eustachian Tube Dysfunction trials