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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
7
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.
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.
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Rochester, New York, United States
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.
Time frame: Baseline to 90 days
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
Time frame: Baseline to 90 days
Change in Percentage of Words Recognized
A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
Time frame: 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.
Time frame: Baseline to 90 days
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