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A Study of a Mastoid Device in Subjects With Ménière's Disease

NCT ID: NCT03520322

Last Updated: 2024-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2024-12-04

Brief Summary

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The purpose of this study is to investigate the efficacy of a mastoid treatment device in patients with active Ménière's disease that is not controlled by traditional medical management

Detailed Description

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This is a single center, randomized, placebo-controlled trial of mastoid oscillation for treatment of Ménière's disease. Eligible subjects will be randomized using a 1:1 allocation to either mastoid oscillation or placebo (oscillator device that provides the same sound but no vibration of the mastoid) received for 30 minutes at four weekly study visits, with efficacy determination via change in frequency and severity of Ménière's symptoms following the final study visit.

Conditions

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Meniere Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Mastoid Oscillator

patients with Menieres Disease

Group Type EXPERIMENTAL

Mastoid Oscillator

Intervention Type DEVICE

The oscillator will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.

Control device

patients with Menieres Disease

Group Type PLACEBO_COMPARATOR

Control Device

Intervention Type DEVICE

The control device will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.

Interventions

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Mastoid Oscillator

The oscillator will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.

Intervention Type DEVICE

Control Device

The control device will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18 and older
2. Clinical diagnosis of Ménière's disease, with classical symptoms:

i. Episodic spinning vertigo ii. Fluctuating unilateral low frequency sensorineural hearing loss iii. Tinnitus iv. Aural fullness c. Failure of traditional medical management of Ménière's disease symptoms d. English language skills sufficient to provide informed consent to the study

Exclusion Criteria

1. Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
2. Bilateral Ménière's disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2365 S. Clinton Ave

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RSRB 63989

Identifier Type: -

Identifier Source: org_study_id