Efficacy of Local Overpressure Treatment for Meniere's Disease

Study Overview
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Brief Summary
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The purpose of this study to date, is that no causal therapy for Meniere's disease has been discovered. Local overpressure treatment for Meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the pathologic hallmark of Meniere's disease. This study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo severity and objective audiovestibular function parameters.

Detailed Description
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Randomized double-blind controlled trial. Patients with unilateral Meniere's disease that suffer from recurring vertigo attacks are allocated to either a verum or a placebo device and are treated for 4 months. Before during and after the treatment period, subjective and objective audiovestibular function parameters are measured.

Official Title
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Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease

Conditions
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Meniere's Disease

Intervention / Treatment
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* Device: Meniett(C) device by MedTronic
* Device: placebo treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral definite Meniere's disease according to the AAO-HNS criteria Exclusion Criteria: previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Local overpressure treatment | Device: Meniett(C) device by MedTronic<br>* pulsed pressure application, up to 12 cm H20 column, 3 times daily for 5 minutes, generated by Meniett device and conducted to middle ear cavity via tympanostomy tube<br>* Other names: Meniett;|
| Placebo Comparator: 2<br>Placebo treatment | Device: placebo treatment<br>* device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vertigo score from pre-therapy to post-therapy. (Vertigo score = summation of daily vertigo severity over 4 weeks. Daily vertigo score = a number between = and 4.) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure tone audiometric thresholds |  | 4 months | 
| Speech recognition hearing levels |  | 4 months | 
| Horizontal semicircular canal paresis |  | 4 Months | 
| Subjective Daily Activity levels (Number between 0 and 4) |  | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meniere, vertigo, overpressure treatment, caloric irrigation, hearing levels, vertigo severity, functional disability scale