Clinical Trial: Efficacy of Local Overpressure Treatment for Meniere's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease
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 Summary: 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.
Sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Current Primary Outcome: 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.) [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pure tone audiometric thresholds [ Time Frame: 4 months ]
- Speech recognition hearing levels [ Time Frame: 4 months ]
- Horizontal semicircular canal paresis [ Time Frame: 4 Months ]
- Subjective Daily Activity levels (Number between 0 and 4) [ Time Frame: 4 Months ]
Original Secondary Outcome: Same as current
Information By: Klinikum der Universitaet Muenchen, Grosshadern
Dates:
Date Received: January 28, 2009
Date Started: August 2005
Date Completion:
Last Updated: April 20, 2009
Last Verified: April 2009
