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Efficacy of Local Overpressure Treatment for Meniere's Disease

This study has been completed.
Sponsor:
Information provided by:
Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier:
NCT00831688
First received: January 28, 2009
Last updated: April 20, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Meniere's Disease
 Device: Meniett(C) device by MedTronic
Device: placebo treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum der Universitaet Muenchen, Grosshadern:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pure tone audiometric thresholds [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Speech recognition hearing levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Horizontal semicircular canal paresis [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • Subjective Daily Activity levels (Number between 0 and 4) [ Time Frame: 4 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Meniett
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 Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831688

Locations
Germany
Klinik für Hals-Nasen-Ohrenheilkunde
München, Bayern, Germany, 81377
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. Eike Krause, Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier: NCT00831688     History of Changes
Other Study ID Numbers: Meniere trial 037/05
Study First Received: January 28, 2009
Last Updated: April 20, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum der Universitaet Muenchen, Grosshadern:
Meniere
vertigo
overpressure treatment
caloric irrigation
 hearing levels
vertigo severity
functional disability scale

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013