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

Meniere Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03520322
• Other study ID #: RSRB 63989
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Meniere Disease

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