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

January 28, 2009
April 20, 2009
August 2005
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00831688 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Local Overpressure Treatment for Meniere's Disease
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Meniere's Disease
  • 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
  • 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
  • Active Comparator: 1
    Local overpressure treatment
    Intervention: Device: Meniett(C) device by MedTronic
  • Placebo Comparator: 2
    Placebo treatment
    Intervention: Device: placebo treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00831688
Meniere trial 037/05
No
Dr. Eike Krause, Klinikum der Universitaet Muenchen, Grosshadern
Klinikum der Universitaet Muenchen, Grosshadern
Not Provided
Principal Investigator: Eike Krause, MD LMU Munich, Department of ENT
Principal Investigator: Robert Gürkov, MD LMU Munich, Department of ENT
Klinikum der Universitaet Muenchen, Grosshadern
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP