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Sponsored by: |
Klinikum der Universitaet Muenchen, Grosshadern |
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Information provided by: | Klinikum der Universitaet Muenchen, Grosshadern |
ClinicalTrials.gov Identifier: | NCT00831688 |
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 |
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Meniere's Disease |
Device: Meniett(C) device by MedTronic Device: placebo treatment |
Phase IV |
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 |
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 |
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1: Active Comparator
Local overpressure treatment
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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
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2: Placebo Comparator
Placebo treatment
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Bayern | |
Klinik für Hals-Nasen-Ohrenheilkunde | |
München, Bayern, Germany, 81377 |
Principal Investigator: | Eike Krause, MD | LMU Munich, Department of ENT |
Principal Investigator: | Robert Gürkov, MD | LMU Munich, Department of ENT |
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 |
Meniere vertigo overpressure treatment caloric irrigation |
hearing levels vertigo severity functional disability scale |
Otorhinolaryngologic Diseases Ménière's Disease Meniere Disease |
Edema Ear Diseases Vertigo |
Otorhinolaryngologic Diseases Endolymphatic Hydrops Meniere Disease Ear Diseases Labyrinth Diseases |