Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

Acoustic overexposure can induced temporary or hearing loss. Usually hearing loss is associated with cochlear cell damages. Recently, a new pathological entity was described and called "hidden hearing loss". In animal model, the histopathology revealed a selective reduction in the number of auditory fibers, resulting in a decrease in the amplitude of wave I of the auditory brainstem response. Electrocochleography (Ecog) is a method for recording the electrical potentials of the cochlea (e.g. wave I). In clinical routine, Ecog is performed invasively with sedation or local anesthesia. Actually, a non invasive approach could be perform but it seems necessary to optimize this method and to define reference values in healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between 18 and 55 years old

be affiliated to a social security system

understand (oral and written) of the French language

be a qualified hearing with normal tympanogram and audiogram

Disqualifiers

have a complaint of hearing

have a exposure to noise (professional and/or activities)

refusal to participate in the study

have ear infections and/or ENT medical history

Trial design

Design model

Single group

Treatments tested in this trial

  • Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways

    Diagnostic test

    Electrocochleography is a technique that analyses the functionality of inner ear.

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: Cohort 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Latency of wave I by electrocochleography

The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)

Time frame
Day 180
2

Latency of wave I by electrocochleography

The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)

Time frame
Day 360

Secondary outcomes

1

Hearing thresholds in decibels

The audiometry will make it possible to obtain the hearing thresholds in decibels for all frequency of 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000, 9000, 10000, 11200, 12500 and 14000 Hz.

Time frame
Day -1 , Day 180, Day 360
2

Acoustic reflex thresholds in decibels

The acoustic reflex allows to evaluate the trigger threshold in decibels of the reflex for the frequencies 500, 1000, 2000, 4000Hz.

Time frame
Day -1 , Day 180, Day 360

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Laboratory of Neurosensory Biophysics - UMR INSERM 1107.

Collaborator

Foundation of Gueules Cassées

Collaborator

Region of Auvergne-Rhône-Alpes

Collaborator