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
About this trial
This is an interventional treatment trial for Meniere Disease
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
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
NCT ID
NCT05582148
First Posted
October 12, 2022
Last Updated
October 12, 2022
Sponsor
University Hospital, Grenoble
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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