Efficacy of Local Overpressure Treatment for Meniere's Disease
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Meniett(C) device by MedTronic
placebo treatment
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere, vertigo, overpressure treatment, caloric irrigation, hearing levels, vertigo severity, functional disability scale
Eligibility Criteria
Inclusion Criteria:
- unilateral definite Meniere's disease according to the AAO-HNS criteria
Exclusion Criteria:
- previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
Sites / Locations
- Klinik für Hals-Nasen-Ohrenheilkunde
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Local overpressure treatment
Placebo treatment
Outcomes
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.)
Secondary Outcome Measures
Pure tone audiometric thresholds
Speech recognition hearing levels
Horizontal semicircular canal paresis
Subjective Daily Activity levels (Number between 0 and 4)
Full Information
NCT ID
NCT00831688
First Posted
January 28, 2009
Last Updated
April 20, 2009
Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
1. Study Identification
Unique Protocol Identification Number
NCT00831688
Brief Title
Efficacy of Local Overpressure Treatment for Meniere's Disease
Official Title
Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere, vertigo, overpressure treatment, caloric irrigation, hearing levels, vertigo severity, functional disability scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Local overpressure treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Device
Intervention Name(s)
Meniett(C) device by MedTronic
Other Intervention Name(s)
Meniett
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
placebo treatment
Other Intervention Name(s)
Placebo
Intervention Description
device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pure tone audiometric thresholds
Time Frame
4 months
Title
Speech recognition hearing levels
Time Frame
4 months
Title
Horizontal semicircular canal paresis
Time Frame
4 Months
Title
Subjective Daily Activity levels (Number between 0 and 4)
Time Frame
4 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral definite Meniere's disease according to the AAO-HNS criteria
Exclusion Criteria:
previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eike Krause, MD
Organizational Affiliation
LMU Munich, Department of ENT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Gürkov, MD
Organizational Affiliation
LMU Munich, Department of ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Hals-Nasen-Ohrenheilkunde
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Local Overpressure Treatment for Meniere's Disease
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