Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

Study Overview
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Brief Summary
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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: Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction Identify patient variables associated with positive response to balloon dilation of the eustachian tube 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-, 12-, 24-, and 52-weeks after the procedure.

Detailed Description
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Adult eustachian tube dilatory dysfunction (ETDD) accounts for over 2 million healthcare visits annually. It can cause longstanding negative middle ear pressure which may lead to otitis media with effusion, tympanic membrane retraction, perforation, middle ear atelectasis and cholesteatoma. Despite this, effective treatments for ETDD are unavailable. Recently, balloon dilation of the eustachian tube (BDET) has gained popularity, where the cartilaginous portion of the Eustachian tube undergoes local dilation with balloon inflation. This technique underwent industry-funded clinical trials in the United States demonstrating its safety and it's superiority to medical management. However, these studies are confounded by industry funding and lack of a blinded control group, the latter of which is critical in a condition where patient-reported outcome measures are relied on. Furthermore, the randomized studies to date do not include patients with baro-challenge ETDD, where symptoms are limited to the context of ambient pressure changes. As such, the investigators opted to perform a non-industry-funded, placebo-controlled trial including both chronic and baro-challenge ETDD patients in a Canadian setting. Potential participants will be identified as possible study candidates with either chronic ETDD or baro-challenge ETDD, who have failed conservative management. At baseline, participants would undergo pure tone audiometry, tympanometry, and otoscopy. An ETDQ7, ad hoc work/activity impairment questionnaire, and EQ-5D-5L questionnaire would be completed. The patient's ability to equalize their middle ear pressure would be assessed by direct visualization of the tympanic membrane as the patient equalizes their middle ear pressure. For patients with baro-challenge ETDD, a baseline ad hoc questionnaire to quantify their symptoms will be completed as well. Patients would then be randomized into BDET versus placebo groups. Patients in the experimental group undergoing BDET in-office will undergo dilation after anxiolytic pre-medication, nasal decongestion, as well as topical anesthesia of the lateral tympanic membrane, the eustachian tube orifice, and the nasal cavity. Patients randomized to the placebo group would undergo a similar procedure in-office, but without dilation of the eustachian tube. Patients in the experimental group with contraindication to in-office BDET will undergo BDET under general anesthetic in an operating room setting. The participants' first follow-up visit with the surgeon is at 6 weeks post-procedure, where patients in the placebo control group would be offered the option to cross-over into the BDET group. Follow up would also be repeated at 12 weeks, 24 weeks, and 52 weeks post-procedure.

Official Title
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Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction: a Randomized, Sham-controlled Trial

Conditions
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Eustachian Tube Dysfunction, Barotitis

Intervention / Treatment
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* Device: Balloon dilation of eustachian tube (Stryker XprESS LoProfile ENT dilation system)
* Other: Sham procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel design with optional crossover from control to intervention at 6 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon dilation of eustachian tube<br>These patient will undergo balloon dilation dilation of the eustachian tube. | Device: Balloon dilation of eustachian tube (Stryker XprESS LoProfile ENT dilation system)<br>* Patients in the intervention group would undergo balloon dilation of the eustachian tube under local anesthetic in clinic. The Stryker XprESS LoProfile ENT dilation system will be used. Participants may undergo dilation under general anesthesia if a contraindication to in-clinic dilation exists.<br>* Other names: Stryker XprESS LoProfile ENT dilation system (Stryker ENT, Plymouth, MN, USA.);|
| Sham Comparator: Sham procedure<br>These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated. | Other: Sham procedure<br>* Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score | Score range 1-7, with higher score indicating more severe symptoms | 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention | 
| Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire) | Composite of quantitative and qualitative data points | 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tympanogram type and pressure at peak compliance | Change from type C to A or type B to C or type B to A is considered improvement, and vice versa is considered deterioration. Pressure at peak compliance (continuous variable, where a value of zero is normal, and more negative values indicate worse ET function). | 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention | 
| Change in audiogram (pure tone average thresholds) | Pure tone average thresholds measured at 500hz, 1khz, 2khz, 4khz, 6khz, and 8khz, where values below 25dB are normal, and higher values indicate worse hearing. Air-bone gap at 500hz, 1khz, 2khz, 4khz where normal value is 0dB, and higher values indicate worse conductive hearing. | 24 weeks | 
| Improvement in ability to equalize middle ear pressure | Qualitative measure where inability to equalize middle ear pressures is a negative outcome. | 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention | 
| Tympanic membrane position on otoscopy | Qualitative measure where the tympanic membrane will be in a normal position, or in an abnormal retracted position. | 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention | 
| Ad hoc work/activity impairment questionnaire score | Score range 1-7, with higher score indicating more severe symptoms | 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BDET, ETD, ETDD, baro-challenge