Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
Eustachian Tube Dysfunction, Barotitis
About this trial
This is an interventional treatment trial for Eustachian Tube Dysfunction focused on measuring BDET, ETD, ETDD, baro-challenge
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.
Sites / Locations
- Otology Clinic, Clinic 7A, South Health CampusRecruiting
- Sunnybrook Health Sciences CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Balloon dilation of eustachian tube
Sham procedure
These patient will undergo balloon dilation dilation of the eustachian tube.
These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.