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โ† Trials
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Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

RecruitingNAAges 18 Years - anyAllUniversity of Calgary
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In plain words

What the trial is, and whether it could suit you

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:

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Balloon dilation of eustachian tube
  • Sham procedure
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Where

2 sites
Otology Clinic, Clinic 7A, South Health Campus
Calgary, Canada
Sunnybrook Health Sciences Center
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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