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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03520322
Other study ID # RSRB 63989
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 29, 2019
Est. completion date February 1, 2025

Study information

Verified date April 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date February 1, 2025
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
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.

Locations

Country Name City State
United States 2365 S. Clinton Ave Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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