NCT05582148

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

October 12, 2022

Last Update Submit

October 12, 2022

Conditions

Meniere DiseaseHearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the comprehension in noise

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

    6 months

Secondary Outcomes (1)

  • Correlation between the ear recruitment and the settings of the hearing aids

    6 months

Interventions

Hearing aids fittingDEVICE

Fitting hearing aids and evaluating the results at 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 30522291RESULT

  • 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.

    PMID: 11893444RESULT

  • 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.

    PMID: 6487852RESULT

  • 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.

    PMID: 19253813RESULT

  • 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.

    PMID: 25029391RESULT

  • 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.

    PMID: 16640056RESULT

MeSH Terms

Conditions

Meniere DiseaseHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesHearing LossHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ashley BAGUANT

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley BAGUANT, MD

CONTACT

+33476765662abaguant@chu-grenoble.fr

Jean Baptiste LEMASSON

CONTACT

+33476765662JBLemasson@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: cohort followed up
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 17, 2022

Study Start

November 15, 2022

Primary Completion

November 15, 2024

Study Completion

December 20, 2024

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share