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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Local overpressure treatment |
|
| 2 | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meniett(C) device by MedTronic | Device | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pure tone audiometric thresholds | 4 months | |
| Speech recognition hearing levels | 4 months | |
| Horizontal semicircular canal paresis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eike Krause, MD | LMU Munich, Department of ENT | Principal Investigator |
| Robert Gürkov, MD | LMU Munich, Department of ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Hals-Nasen-Ohrenheilkunde | München | Bavaria | 81377 | Germany |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D062086 | Transtympanic Micropressure Treatment |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| placebo treatment | Device | device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation. |
|
|
| 4 Months |
| Subjective Daily Activity levels (Number between 0 and 4) | 4 Months |
| D015837 |
| Vestibular Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |