Efficacy of Local Overpressure Treatment for Meniere's Disease

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00831688

Enrollment

Registered

2009-01-29

Start date

2005-08-31

Completion date

2009-04-30

Last updated

2009-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere's Disease

Keywords

Meniere, vertigo, overpressure treatment, caloric irrigation, hearing levels, vertigo severity, functional disability scale

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.

Interventions

DEVICEMeniett(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

DEVICEplacebo 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Design outcomes

Primary

Measure	Time frame
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.)	4 months

Secondary

Measure	Time frame
Pure tone audiometric thresholds	4 months
Speech recognition hearing levels	4 months
Horizontal semicircular canal paresis	4 Months
Subjective Daily Activity levels (Number between 0 and 4)	4 Months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026