Hearing LossMELAUDI-2NCT03552224
Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans
A study testing Recording of auditory nerve activity in people with Hearing Loss, run by University Hospital, Montpellier at 1 site in France.
Trial summary
To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Recording of auditory nerve activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2018to 26 Jun 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 80 years ( inclusive borders)
- patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and
- Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or
- Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2).
- Voluntary subjects to participate in the study,
- Subjects having signed written consent to participate in the study,
- Easily accessible topics.
Who cannot join
- Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator,
- Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed,
- Subjects for whom there is a contraindication to general anesthesia,
- Subjects with a central neurological pathology that can disrupt electrophysiological recordings
- Not affiliated to a French social security scheme or not benefiting from such a scheme,
- Majors protected by law,
Show all 9Show fewer
- Pregnant women,
- deprived of liberty by judicial or administrative decision,
- Infectious or inflammatory pathology of the middle ear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2
To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.
- Conditions
- Hearing Loss
- Being tested
- Recording of auditory nerve activity
- Keywords
- Evoked auditory nerve activity, Hearing Loss, Tinnitus
- Medical subject headings
- Hearing Loss, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of auditory nerve activityProcedure or surgery
near field recording of auditory nerve activity with contact electrode
| Study group | Role | What they receive |
|---|---|---|
| Subjects with no hearing loss | Experimental | Subjects referred for cerebellopontine angle surgery with no hearing loss with recording of auditory nerve activity by contact electrode Receives: Procedure: Recording of auditory nerve activity |
| Subjects with hearing loss | Experimental | Subjects referred for cerebellopontine angle surgery with hearing loss with recording of auditory nerve activity by contact electrode Receives: Procedure: Recording of auditory nerve activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of global evoked auditory nerve activity
Measured: 36 months
Spectrum of global evoked auditory nerve activity
Measured: 36 months
Secondary outcomes (1)
Mesure of peristimulus time responses of evoked auditory nerve activity
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start11 Jul 2018
- Primary completion26 Jun 2021
- Study completion26 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Neurosciences of Montpellier U1051, Reims University hospital
- Responsible party
- Sponsor
- Investigators
- Frédéric VENAIL, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552224
- Sponsor's protocol ID
- 9890
- Acronym
- MELAUDI-2
- Status last verified
- Dec 2021
- First submitted
- 23 May 2018
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2
- ClinicalTrials.gov ID
- NCT03552224
- Acronym / sponsor ID
- MELAUDI-2 / 9890
- Conditions
- Hearing Loss
- Keywords
- Evoked auditory nerve activity, Hearing Loss, Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institute for Neurosciences of Montpellier U1051, Reims University hospital
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 11 Jun 2018 (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.
To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with no hearing loss | Experimental | Procedure: Recording of auditory nerve activitySubjects referred for cerebellopontine angle surgery with no hearing loss with recording of auditory nerve activity by contact electrode |
| Subjects with hearing loss | Experimental | Procedure: Recording of auditory nerve activitySubjects referred for cerebellopontine angle surgery with hearing loss with recording of auditory nerve activity by contact electrode |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 - 80 years ( inclusive borders)
- patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and
- Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or
- Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2).
- Voluntary subjects to participate in the study,
Key exclusion criteria (9 listed)
- Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator,
- Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed,
- Subjects for whom there is a contraindication to general anesthesia,
- Subjects with a central neurological pathology that can disrupt electrophysiological recordings
- Not affiliated to a French social security scheme or not benefiting from such a scheme,
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 |
|---|---|---|
| Recording of auditory nerve activitynear field recording of auditory nerve activity with contact electrode | Procedure or surgery | Subjects with hearing loss, Subjects with no hearing loss |
Primary outcome
Amplitude of global evoked auditory nerve activity
Time frame: 36 months
Spectrum of global evoked auditory nerve activity
Time frame: 36 months
1 secondary outcome
Mesure of peristimulus time responses of evoked auditory nerve activity
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
Frédéric VENAIL, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording of auditory nerve activity in people with Hearing Loss, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of global evoked auditory nerve activity (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2021.