Efficacy of Local Overpressure Treatment for Meniere's Disease

Klinikum der Universitaet Muenchen, Grosshadern

Status and phase: Completed; Phase 4

Conditions: Meniere's Disease

Treatments: Device: Meniett(C) device by MedTronic; Device: placebo treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00831688

Meniere trial 037/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Local overpressure treatment

Treatment:

Device: Meniett(C) device by MedTronic

2

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Device: placebo treatment