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MMA: Meniere Disease and Hearing Aids

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05582148
Collaborator
(none)
10
Enrollment
25.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing aids fitting
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
cohort followed upcohort followed up
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Meniere Disease and Hearing Aids
Anticipated Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Nov 15, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the comprehension in noise [6 months]

    Evaluation with the FrMatrix test of the noise comprehension at 6 months

Secondary Outcome Measures

  1. Correlation between the ear recruitment and the settings of the hearing aids [6 months]

    Correlation between the fowler test and the MPO modifications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Ashley BAGUANT, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT05582148
Other Study ID Numbers:
  • 38RC22.0289
First Posted:
Oct 17, 2022
Last Update Posted:
Oct 17, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Meniere Disease
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Oct 17, 2022