Actively Recruiting
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
Led by University of Calgary · Updated on 2025-04-03
76
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with more than 3 months of symptoms of eustachian tube dysfunction such as ear pain, pressure, muffled hearing, tinnitus, cracking or popping, or feeling clogged
- Symptoms persist despite more than 4 weeks of intranasal corticosteroids or more than 7 days of systemic steroids within 6 months before enrollment
- Documented Type B or C tympanogram at or within 6 months before enrollment
- Eustachian Tube Dysfunction Questionnaire (ETDQ7) score of 2.1 or higher at enrollment
- For baro-challenge ETDD: more than 12 months of symptoms triggered by pressure changes occurring at least every 4 months within the past year
- Baro-challenge symptoms include ear pain, pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged, vertigo, or facial nerve palsy that resolve within 3 days after pressure equalization
- Failure of at least one treatment such as topical or oral decongestants, pneumatization devices, or pressure relief ear plugs
You will not qualify if you...
- Signs or symptoms of patulous eustachian tube dysfunction such as hearing your own voice loudly or ear drum movement with breathing
- Need for additional surgical procedures like septoplasty or ear tube placement
- Presence of a perforated eardrum or existing ear tubes
- Fluctuating sensorineural hearing loss, acute otitis media, severe eardrum retraction, or tympanosclerosis affecting more than half of the eardrum
- Uncontrolled sinus or nasal disease, reflux, temporomandibular joint disorder, immune deficiency, or allergies
- Known internal carotid artery exposure near the eustachian tube on the affected ear
- Recent head or neck surgery within 3 months or planned surgery during the study
- History of radiation therapy to the head or neck
- History of craniofacial abnormalities
- Previous eustachian tube interventions
- Psychiatric or cognitive conditions that prevent informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Otology Clinic, Clinic 7A, South Health Campus
Calgary, Alberta, Canada
Actively Recruiting
2
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Actively Recruiting
Research Team
J
Jaimi Workun
CONTACT
M
Mohammad Aleinati, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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