A Phase 4 interventional study of Meniett(C) device by MedTronic and placebo treatment in Meniere's Disease, sponsored by Klinikum der Universitaet Muenchen, Grosshadern. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-21.
Sponsored by Klinikum der Universitaet Muenchen, Grosshadern · Phase 4, Interventional, and Treatment
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.
77 studies on the registry are indexed under Meniere Disease; 14 are open to participants now.
This study's planned enrollment of 80 is above the median of 49 across 64 interventional studies indexed under Meniere Disease.
Browse Meniere Disease studies →Klinikum der Universitaet Muenchen, Grosshadern is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Local overpressure treatment
Device: Meniett(C) device by MedTronic
Placebo treatment
Device: placebo treatment
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
Also known as: Meniett
device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.
Also known as: Placebo
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
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
The record gives a start of Aug 2005, a primary completion of Apr 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Klinikum der Universitaet Muenchen, Grosshadern