Meniere Disease and Hearing Aids (MMA)

October 12, 2022 updated by: University Hospital, Grenoble

Patients with unilateral Meniere Disease often a distortion that causes difficulties to provide hearing aids to these patients. Those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis.

Due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients.

Our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 y.o
  • Meniere disease as define by the Barany Society
  • Unilateral deafness with a threshold over 50dB
  • Normal ear with a threshold above 30dB
  • Interaural threshold difference of at least 30dB
  • Patient who has already an hearing aids and satisfied with it

Exclusion Criteria:

  • Absence of consent of the patient or not able to give it
  • Patient with hearing aids well fitted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the comprehension in noise
Time Frame: 6 months
Evaluation with the FrMatrix test of the noise comprehension at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the ear recruitment and the settings of the hearing aids
Time Frame: 6 months
Correlation between the fowler test and the MPO modifications
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Ashley BAGUANT, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2022

Primary Completion (Anticipated)

November 15, 2024

Study Completion (Anticipated)

December 20, 2024

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC22.0289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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