Meniere Disease and Hearing Aids | NCT05582148

Studies
Meniere Disease and Hearing Aids

NCT05582148

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Oct 17, 2022Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Meniere Disease
Hearing Loss, Sensorineural

Interventions

Hearing aids fitting

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2022Estimated

Primary Completion Date

Nov 15, 2024Estimated

Completion Date

Dec 20, 2024Estimated

First Submitted Date

Oct 12, 2022

First Submission Date that Met QC Criteria

Oct 12, 2022

First Posted Date

Oct 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2022

Last Update Posted Date

Oct 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hearing aids fitting	Device	Fitting hearing aids and evaluating the results at 6 months

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ashley BAGUANT, MD	Contact	+33476765662		abaguant@chu-grenoble.fr
Jean Baptiste LEMASSON	Contact	+33476765662		JBLemasson@chu-grenoble.fr

Overall Officials

Name	Affiliation	Role
Ashley BAGUANT	University Hospital, Grenoble	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30522291	Result	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.
11893444	Result	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.

ID	Term
D018159	Endolymphatic Hydrops
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D008575	Meniere Disease
D006319	Hearing Loss, Sensorineural