NCT00831688

Efficacy of Local Overpressure Treatment for Meniere's Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Klinikum der Universitaet Muenchen, Grosshadern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Meniere's Disease

Interventions

Type	Name	Description
DEVICE	Meniett(C) device by MedTronic	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
DEVICE	placebo treatment	device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.

Timeline

• Start date: 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 across 1 country: Germany