Efficacy of Local Overpressure Treatment for Meniere's Disease - Full Text View

Sponsored by:	Klinikum der Universitaet Muenchen, Grosshadern
Information provided by:	Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier:	NCT00831688

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 IV

MedlinePlus related topics: Dizziness and Vertigo Meniere's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease

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
1: Active Comparator 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
2: Placebo Comparator 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.

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, Bayern
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:	Klinikum der Universitaet Muenchen, Grosshadern ( Dr. Eike Krause )
Study ID Numbers:	Meniere trial 037/05
Study First Received:	January 28, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00831688 History of Changes
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

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Ménière's Disease
Meniere Disease

Edema
Ear Diseases
Vertigo

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Endolymphatic Hydrops
Meniere Disease
Ear Diseases
Labyrinth Diseases

ClinicalTrials.gov processed this record on May 06, 2009