Efficacy of Local Overpressure Treatment for Meniere's Disease

Phase 4

Completed

• Conditions: Meniere's Disease
• Interventions: Device: Meniett(C) device by MedTronic; Device: placebo treatment

• Registration Number: NCT00831688
• Lead Sponsor: Klinikum der Universitaet Muenchen, Grosshadern

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-20
• Last Update Posted: 2009-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• unilateral definite Meniere's disease according to the AAO-HNS criteria

Exclusion Criteria

• previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Meniett(C) device by MedTronic	Local overpressure treatment
2	placebo treatment	Placebo treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Klinik für Hals-Nasen-Ohrenheilkunde; 🇩🇪 München, Bayern, Germany