Efficacy of Local Overpressure Treatment for Meniere's Disease

April 20, 2009 updated by: Klinikum der Universitaet Muenchen, Grosshadern

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • München, Bayern, Germany, 81377
        • Klinik für Hals-Nasen-Ohrenheilkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo treatment
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.
Other Names:
  • Placebo
Active Comparator: 1
Local overpressure treatment
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
Other Names:
  • Meniett

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pure tone audiometric thresholds
Time Frame: 4 months
4 months
Speech recognition hearing levels
Time Frame: 4 months
4 months
Horizontal semicircular canal paresis
Time Frame: 4 Months
4 Months
Subjective Daily Activity levels (Number between 0 and 4)
Time Frame: 4 Months
4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum der Universitaet Muenchen, Grosshadern

Investigators

  • Principal Investigator: Eike Krause, MD, LMU Munich, Department of ENT
  • Principal Investigator: Robert Gürkov, MD, LMU Munich, Department of ENT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2009

Last Update Submitted That Met QC Criteria

April 20, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meniere trial 037/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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