BridgeMD
Tests treatment safety and results for Eustachian Tube Dysfunction
Official title Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
ClinicalTrials.gov ID: NCT05719207
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (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 (baro-challenge ETDD):
You likely can't join if
- 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
See the full eligibility 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 (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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.