Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction: a Randomized, Sham-controlled Trial
University of Calgary
76 participants
Jun 25, 2023
INTERVENTIONAL
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
Inclusion Criteria7
- >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
- >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 Criteria11
- 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.
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Interventions
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.
Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05719207