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Efficacy of Local Overpressure Treatment for Meniere's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00831688
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : April 21, 2009
Information provided by:
Klinikum der Universitaet Muenchen, Grosshadern

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease
Study Start Date : August 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pure tone audiometric thresholds [ Time Frame: 4 months ]
  2. Speech recognition hearing levels [ Time Frame: 4 months ]
  3. Horizontal semicircular canal paresis [ Time Frame: 4 Months ]
  4. Subjective Daily Activity levels (Number between 0 and 4) [ Time Frame: 4 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00831688

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Klinik für Hals-Nasen-Ohrenheilkunde
München, Bayern, Germany, 81377
Sponsors and Collaborators
Klinikum der Universitaet Muenchen, Grosshadern
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Principal Investigator: Eike Krause, MD LMU Munich, Department of ENT
Principal Investigator: Robert Gürkov, MD LMU Munich, Department of ENT
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Responsible Party: Dr. Eike Krause, Klinikum der Universitaet Muenchen, Grosshadern Identifier: NCT00831688    
Other Study ID Numbers: Meniere trial 037/05
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: April 21, 2009
Last Verified: April 2009
Keywords provided by Klinikum der Universitaet Muenchen, Grosshadern:
overpressure treatment
caloric irrigation
hearing levels
vertigo severity
functional disability scale
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases