Efficacy of Local Overpressure Treatment for Meniere's Disease

NCT00831688 — Phase 4, Completed, 80 participants, Klinikum der Universitaet Muenchen, Grosshadern

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

Registry	NCT00831688
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	80 (Estimated)
Sponsor	Klinikum der Universitaet Muenchen, Grosshadern (Other)
Conditions	Meniere's Disease
Interventions	Meniett(C) device by MedTronic, placebo treatment (Device)
Dates	start 2005-08-01, primary completion 2009-04-01, completion 2009-04-01, first posted 2009-01-29, last updated 2009-04-21
Locations	1 site in Germany

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
1	Active comparator	Device: Meniett(C) device by MedTronic	Local overpressure treatment
2	Placebo comparator	Device: placebo treatment	Placebo treatment

Meniett(C) device by MedTronic (Device), also known as Meniett: 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
placebo treatment (Device), also known as Placebo: device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

+Locations (1)

Facility	City	Country	Status
Klinik für Hals-Nasen-Ohrenheilkunde	München, Bavaria	Germany

+Investigators

Eike Krause, MD, Principal investigator, LMU Munich, Department of ENT
Robert Gürkov, MD, Principal investigator, LMU Munich, Department of ENT