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Completed

NCT Number: NCT00831688

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.

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Key information

Conditions

Meniere's Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik für Hals-Nasen-Ohrenheilkunde

München, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Treatment and study plan

Meniett(C) device by MedTronic

Device

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 names: Meniett

Placebo treatment

Device

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 names: Placebo

Primary outcomes

  1. 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 outcomes

  1. Pure tone audiometric thresholds

    Time frame: 4 months

  2. Speech recognition hearing levels

    Time frame: 4 months

  3. Horizontal semicircular canal paresis

    Time frame: 4 Months

  4. Subjective Daily Activity levels (Number between 0 and 4)

    Time frame: 4 Months

Sponsors and collaborators

Lead sponsor

Klinikum der Universitaet Muenchen, Grosshadern

Other

Registry information

Official study title

Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2009
Registry last updated
Apr 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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