Balloon Dilation of the Eustachian Tube

Study Overview
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Brief Summary
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In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. balloon dilation of the eustachian tube or nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

Detailed Description
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Patients will eustachian tube dysfunction will be asked to participate in the study. They will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaesthesia group 2 - daily nasal saline spray, twice a day Regular Follow up with Tympanogram and Questionnaire After three months patient in the control group (nasal saline) can switch in the intervention group. Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.

Official Title
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A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon

Conditions
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Eustachian Tube Dysfunction

Intervention / Treatment
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* Device: Balloon dilation of the eustachian tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old (of both sexes) Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral Diagnosis (both required): i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment. ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment). Exclusion Criteria: Patulous eustachian tube Prior eustachian tube intervention Presence of myringotomy ventilation tube or a tympanic membrane perforation Active chronic or acute otitis media Chronic otitis media with cholesteatoma Fluctuating sensorineural hearing loss or Meniere's disease Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication History of head or neck surgery within 3 months Prior radiation to the head and neck Active temporomandibular joint disorders Cleft palate or Craniofacial syndrome Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies Active acute upper respiratory infection Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression Patient unable to follow protocol for any reason

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: Crossover Assignment
Interventional Model Description: Cross Over after 3 months possible
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eustachian tube dilation<br>Surgical Eustachian tube dilation in general anaesthesia | Device: Balloon dilation of the eustachian tube<br>* Balloon dilation of the eustachian tube<br>|
| No Intervention: Control Group<br>nasal saline spray | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 6 weeks | 
| Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 3 motnths | 
| Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 6 months | 
| Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 6 weeks | 
| Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 3 months | 
| Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 6 months | 
| Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 12 months | 
| Tympanogram | Measurement with tympanometer | 3 months | 
| Tympanogram | Measurement with tympanometer | 6 months | 
| Tympanogram | Measurement with tympanometer | 12 months | 
| ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 6 weeks | 
| ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 3 months | 
| ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 6 months | 
| ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 12 months | 
| HUI (Health utility index) | Questionnaire | 6 weeks | 
| HUI (Health utility index) | Questionnaire | 3 months | 
| HUI (Health utility index) | Questionnaire | 6 months | 
| HUI (Health utility index) | Questionnaire | 12 months |