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

Study Overview
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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.

Official Title
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A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease

Conditions
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Meniere Disease

Intervention / Treatment
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* Device: Mastoid Oscillator
* Device: Control Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 and older 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: Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis Bilateral Ménière's disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mastoid Oscillator<br>patients with Menieres Disease | Device: Mastoid Oscillator<br>* 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.<br>|
| Placebo Comparator: Control device<br>patients with Menieres Disease | Device: Control Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of monthly vertigo episodes | A patient reported measure of the number of vertigo episodes they have experienced in the past month. | Baseline to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average pure tone threshold | The audiometric thresholds measured at 500 Hz, 1, 2, & 4 kHz under controlled conditions are averaged together to create the average pure tone threshold | Baseline to 90 days | 
| Change in word recognition score | A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions | Baseline to 90 days | 
| Change in Meniere's functional level | A patient reported measure of their overall function from 0 to 6 where 0 corresponds to no symptoms and 6 corresponds to completely debilitated. | Baseline to 90 days |