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

Not Applicable

Terminated

Conditions: Meniere Disease

Interventions: Device: Control Device
Device: Mastoid Oscillator

Registration Number: NCT03520322

Lead Sponsor: University of Rochester

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control device	Control Device	patients with Menieres Disease
Mastoid Oscillator	Mastoid Oscillator	patients with Menieres Disease

Primary Outcome Measures

Name	Time	Method
Change in the Number of Monthly Vertigo Episodes	Baseline to 90 days	A patient reported measure of the number of vertigo episodes they have experienced in the past month.

Secondary Outcome Measures

Name	Time	Method
Change in Average Pure Tone Threshold	Baseline to 90 days	The audiometric thresholds measured at 500 Hz, 1, 2, \& 4 kHz under controlled conditions are averaged together to create the average pure tone threshold
Change in Percentage of Words Recognized	Baseline to 90 days	A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
Change in Meniere's Functional Level	Baseline to 90 days	A patient reported measure of their overall function from 0 to 6 where 0 corresponds to no symptoms and 6 corresponds to completely debilitated.