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lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eustachian tube dilation | Experimental | Surgical Eustachian tube dilation in general anaesthesia |
|
| Control Group | No Intervention | nasal saline spray |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon dilation of the eustachian tube | Device | Balloon dilation of the eustachian tube |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Trung N Le, MD, PhD | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Center | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008607 | Derived | Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2. |
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Cross Over after 3 months possible
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| 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 |