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Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans

Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03552224
Acronym
MELAUDI-2
Enrollment
30
Registered
2018-06-11
Start date
2018-07-11
Completion date
2021-06-26
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Evoked auditory nerve activity, Hearing Loss, Tinnitus

Brief 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 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.

Interventions

PROCEDURERecording of auditory nerve activity

near field recording of auditory nerve activity with contact electrode

Sponsors

Institute for Neurosciences of Montpellier U1051
CollaboratorUNKNOWN
Reims University hospital
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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, * Pregnant women, * deprived of liberty by judicial or administrative decision, * Infectious or inflammatory pathology of the middle ear.

Design outcomes

Primary

MeasureTime frame
Amplitude of global evoked auditory nerve activity36 months
Spectrum of global evoked auditory nerve activity36 months

Secondary

MeasureTime frame
Mesure of peristimulus time responses of evoked auditory nerve activity36 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026