Efficacy of Local Overpressure Treatment for Meniere's Disease

Meniere's Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

• NCT number: NCT00831688
• Study type: Interventional
• Source: Klinikum der Universitaet Muenchen, Grosshadern
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Completion date: April 2009