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Meniere Disease and Hearing Aids (MMA)

Primary Purpose

Meniere Disease, Hearing Loss, Sensorineural

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aids fitting
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Correlation between the ear recruitment and the settings of the hearing aids
    Correlation between the fowler test and the MPO modifications

    Full Information

    First Posted
    October 12, 2022
    Last Updated
    October 12, 2022
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05582148
    Brief Title
    Meniere Disease and Hearing Aids
    Acronym
    MMA
    Official Title
    Meniere Disease and Hearing Aids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2022 (Anticipated)
    Primary Completion Date
    November 15, 2024 (Anticipated)
    Study Completion Date
    December 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meniere Disease, Hearing Loss, Sensorineural

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    cohort followed up
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Hearing aids fitting
    Intervention Description
    Fitting hearing aids and evaluating the results at 6 months
    Primary Outcome Measure Information:
    Title
    Evaluation of the comprehension in noise
    Description
    Evaluation with the FrMatrix test of the noise comprehension at 6 months
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Correlation between the ear recruitment and the settings of the hearing aids
    Description
    Correlation between the fowler test and the MPO modifications
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashley BAGUANT, MD
    Phone
    +33476765662
    Email
    abaguant@chu-grenoble.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jean Baptiste LEMASSON
    Phone
    +33476765662
    Email
    JBLemasson@chu-grenoble.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashley BAGUANT
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30522291
    Citation
    Cubick J, Buchholz JM, Best V, Lavandier M, Dau T. Listening through hearing aids affects spatial perception and speech intelligibility in normal-hearing listeners. J Acoust Soc Am. 2018 Nov;144(5):2896. doi: 10.1121/1.5078582.
    Results Reference
    result
    PubMed Identifier
    11893444
    Citation
    Havia M, Kentala E, Pyykko I. Hearing loss and tinnitus in Meniere's disease. Auris Nasus Larynx. 2002 Apr;29(2):115-9. doi: 10.1016/s0385-8146(01)00142-0.
    Results Reference
    result
    PubMed Identifier
    6487852
    Citation
    Hood JD. Speech discrimination in bilateral and unilateral hearing loss due to Meniere's disease. Br J Audiol. 1984 Aug;18(3):173-7. doi: 10.3109/03005368409078945.
    Results Reference
    result
    PubMed Identifier
    19253813
    Citation
    McNeill C, McMahon CM, Newall P, Kalantzis M. Hearing aids for Meniere's syndrome: implications of hearing fluctuation. J Am Acad Audiol. 2008 May;19(5):430-4. doi: 10.3766/jaaa.19.5.5.
    Results Reference
    result
    PubMed Identifier
    25029391
    Citation
    Sato G, Sekine K, Matsuda K, Ueeda H, Horii A, Nishiike S, Kitahara T, Uno A, Imai T, Inohara H, Takeda N. Long-term prognosis of hearing loss in patients with unilateral Meniere's disease. Acta Otolaryngol. 2014 Oct;134(10):1005-10. doi: 10.3109/00016489.2014.923114. Epub 2014 Jul 16.
    Results Reference
    result
    PubMed Identifier
    16640056
    Citation
    Valente M, Mispagel K, Valente LM, Hullar T. Problems and solutions for fitting amplification to patients with Meniere's disease. J Am Acad Audiol. 2006 Jan;17(1):6-15. doi: 10.3766/jaaa.17.1.2.
    Results Reference
    result

    Learn more about this trial

    Meniere Disease and Hearing Aids

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