Balloon dilation procedure for treating Eustachian tube dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jaimi.workun@albertahealthservices.ca
• Phone: 403-764-4755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nasal Dilator Therapy for Patulous Eustachian Tube

  This study tests whether wearing a nasal dilator helps reduce symptoms in adults with patulous Eustachian tube dysfunction.

  Recruiting The Methodist Hospital Research Institute · Houston, Texas · NCT07796139

• Buteyko breathing plus smoking-hygiene for adolescents with passive household smoke exposure and chronic Eustachian tube dysfunction

  This project will test whether adding regular Buteyko breathing exercises to smoking-hygiene education helps adolescents exposed to household tobacco smoke who have chronic Eustachian tube dysfunction and reduced lung function.

  Recruiting Cairo University · Giza, Dokki · NCT07236580

• Buteyko breathing for seniors with chronic obstructive Eustachian tube dysfunction

  This trial will try adding daily Buteyko breathing exercises to usual care to see if it helps seniors with chronic Eustachian tube dysfunction.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07193485

• New nasal spray delivery system for treating Eustachian tube dysfunction

  This study tests a new nasal spray to see if it can help people with Eustachian tube dysfunction feel better by delivering medication more effectively.

  Recruiting at 4 sites Phase 2 Cedars-Sinai Medical Center · Los Angeles, California and 3 other locations · NCT05275686

• Evaluating balloon sinuplasty for maxillary sinusitis

  This study is testing if balloon sinuplasty can help people with chronic or recurrent maxillary sinusitis feel better compared to a fake surgery.

  Recruiting Tampere University Hospital · Tampere · NCT04645511

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.