Efficacy of Local Overpressure Treatment for Meniere's Disease

Meniere's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831688
• Other study ID #: Meniere trial 037/05
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2009
• Last updated: April 20, 2009
• Start date: August 2005
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Klinikum der Universitaet Muenchen, Grosshadern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

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
• 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.

Locations

Country	Name	City	State
Germany	Klinik für Hals-Nasen-Ohrenheilkunde	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen, Grosshadern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pure tone audiometric thresholds		4 months	No
Secondary	Speech recognition hearing levels		4 months	No
Secondary	Horizontal semicircular canal paresis		4 Months	No
Secondary	Subjective Daily Activity levels (Number between 0 and 4)		4 Months	No