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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
Klinikum der Universitaet Muenchen, Grosshadern
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 28, 2009
Last Updated
April 20, 2009
Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
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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

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Efficacy of Local Overpressure Treatment for Meniere's Disease

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