Meniere DiseaseMMANCT05582148
Meniere Disease and Hearing Aids
A study testing Hearing aids fitting in people with Meniere Disease and Hearing Loss, Sensorineural, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere Disease, Hearing Loss, Sensorineural
- What is being tested?
- Hearing aids fitting
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Absence of consent of the patient or not able to give it
- Patient with hearing aids well fitted
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Meniere Disease, Hearing Loss, Sensorineural
- Being tested
- Hearing aids fitting
- Medical subject headings
- Meniere Disease, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aids fittingDevice
Fitting hearing aids and evaluating the results at 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the comprehension in noise
Evaluation with the FrMatrix test of the noise comprehension at 6 months
Measured: 6 months
Secondary outcomes (1)
Correlation between the ear recruitment and the settings of the hearing aids
Correlation between the fowler test and the MPO modifications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Nov 2022 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort followed up
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley BAGUANT, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582148
- Sponsor's protocol ID
- 38RC22.0289
- Acronym
- MMA
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30522291Havia 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.
PubMed 11893444Hood 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.
PubMed 6487852McNeill 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.
PubMed 19253813Sato 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.
PubMed 25029391Valente 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.
PubMed 16640056
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meniere Disease and Hearing Aids
- ClinicalTrials.gov ID
- NCT05582148
- Acronym / sponsor ID
- MMA / 38RC22.0289
- Conditions
- Meniere Disease, Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- cohort followed up
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Absence of consent of the patient or not able to give it
- Patient with hearing aids well fitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aids fittingFitting hearing aids and evaluating the results at 6 months | Device | – |
Primary outcome
Evaluation of the comprehension in noise
Time frame: 6 months
Evaluation with the FrMatrix test of the noise comprehension at 6 months
1 secondary outcome
Correlation between the ear recruitment and the settings of the hearing aids
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Results publication: PubMed 30522291Cubick 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 publication: PubMed 11893444Havia 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 publication: PubMed 6487852Hood 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 publication: PubMed 19253813McNeill 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 publication: PubMed 25029391Sato 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 publication: PubMed 16640056Valente 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley BAGUANT principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aids fitting in people with Meniere Disease and Hearing Loss, Sensorineural, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley BAGUANT, MD (+33476765662, abaguant@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the comprehension in noise (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582148, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.