Actively Recruiting
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction A Randomized, Sham-controlled Trial
Led by University of Calgary · Updated on 2025-04-03
76
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of balloon dilation of the eustachian tube to treat adults with eustachian tube dilatory dysfunction (ETDD), including chronic and baro-challenge types. This condition can cause long-term ear problems due to negative middle ear pressure, and current treatments like steroid sprays or ear tubes may be ineffective or carry risks. The study aims to see if balloon dilation works better than a placebo, identify which patients respond well, and confirm the safety of the procedure. Participants will be randomly assigned to receive either balloon dilation of the eustachian tube or a sham procedure that mimics the motions without actual dilation. The balloon dilation is done in-office using specialized devices under local anesthesia or under general anesthesia if needed. Those in the placebo group will have the option to receive balloon dilation six weeks later. Follow-up visits occur at 6, 24, and 52 weeks to monitor progress. During the study, participants complete questionnaires about their ear symptoms, quality of life, and work impact. They will also undergo hearing tests, ear drum movement assessments, tympanometry, and visual ear examinations before and after the procedures at specified intervals. Researchers will measure changes in symptom scores, hearing, ear drum position, and ability to equalize ear pressure to evaluate treatment effects and safety over one year.
CONDITIONS
Brief 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 aged 18 years or older
- Symptoms of chronic ETDD lasting more than 3 months with persistent ear-related symptoms
- Symptoms persisting despite at least 4 weeks of intranasal corticosteroids or a 7-day course of systemic steroids within 6 months prior to enrollment
- Documented Type B or C tympanogram within 6 months of enrollment
- ETDQ7 score of 2.1 or higher at enrollment
- For baro-challenge ETDD: symptoms occurring at least every 4 months over the past year
- Symptoms include ear pain, pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged, vertigo, or facial nerve palsy that resolve within 3 days of 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 autophony or ear drum movement with breathing
- Need for additional surgical procedures like septoplasty or ear tube placement
- Presence of tympanic membrane perforation or ear tubes
- Fluctuating sensorineural hearing loss, acute otitis media, severe ear drum retraction, or extensive tympanosclerosis
- Uncontrolled sinus disease, reflux, temporomandibular joint disorder, immunodeficiency, or allergies
- Known internal carotid artery dehiscence of the bony eustachian tube
- Recent head and neck surgery within 3 months or planned surgery during the study
- History of radiation to the head and neck
- Presence of craniofacial abnormalities
- Prior eustachian tube interventions
- Psychiatric or cognitive conditions preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo either balloon dilation of the eustachian tube or a sham procedure in an in-office setting or operating room under anesthesia.
1 procedure visit (in-person)
Duration - Up to 52 weeks post-procedure
Participants have follow-up visits to assess treatment outcomes and may cross over from sham to balloon dilation after 6 weeks.
Visits at 6 weeks, 24 weeks, and 52 weeks post-procedure
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
M
Mohammad Aleinati, MD
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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