Clinical trial NCT04198909: Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
Official title: Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteer
Without Hearing Disorders
Keywords: hidden hearing loss
questionnaire
hearing screening
electrocochleography
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratory of Neurosensory Biophysics - UMR INSERM 1107.
name: Foundation of Gueules Cassées
name: Region of Auvergne-Rhône-Alpes
First posted: 2019-12-13
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The sound overexposure is a major cause of hearing disorders. The installation of hearing disorders can be temporary or permanent. Most of the time the investigators see a rise in hearing thresholds that can be accompanied by tinnitus. However, sometimes-hearing disorders aren't characterized by higher auditory threshold but by a complaint of understanding in noise. Two explanation are the either possible with a lesion at the peripheral level (sensory organ) or central lesion (auditory pathways). Peripheral damage is easily analysed by conventional tests such as the audiogram. Concerning the central lesions, through to the Electrocochleography, one sees a diminution of the wave I which corresponds to the nerve fiber injury. The wave I can more easily be analysed by the Electrocochleography method. This technique previously used an electrode deposited trans-tympanically in contact with the sensory organ. But, the evolution of a non-invasive technique is now available. However, several assemblies of the electrode are then possible without knowing the impact of these on the morphology of the wave I. Moreover, no normative values are also referenced in the literature on the population without hearing problems. It's in this context that clinical study is carried out in order to optimize the technique on the assembly of the electrode and the acoustic stimulation delivered. After this analyses and obtaining an optimal technique it's envisaged to study the morphology of the wave I in healthy volunteers aged 18-25 years. A pre-inclusion visit will verify the volunteers doesn't have a hearing disorders through a questionnaire, otoscopy, tympanometry and audiometry. Then two steps will be realized. The first is to evaluate the morphology of wave I according to assembly of electrode and acoustic stimulation delivered (machine calibration or calibration in the external auditory canal). The second step will provide normative values for people 18-25 years old who aren't hearing-impaired. Volunteers will have the choice to participate in one or both stages. The aim is to obtain wave I reference values for Electrocochleography technique. The secondary objectives are to analyse the impact of the assembly of the electrode and the adaptation of the acoustic stimulation presented.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* have cardiovascular, metabolic, neurological and psychiatric desease
* being a protected person
* healthy volunteer who has received compensation equal to or greader than 4500€ in clinical study

Primary outcomes:
measure: Latency of wave I by electrocochleography
timeFrame: Day 180
measure: Latency of wave I by electrocochleography
timeFrame: Day 360
Secondary outcomes:
measure: Hearing thresholds in decibels
timeFrame: Day -1 , Day 180, Day 360
measure: Acoustic reflex thresholds in decibels
timeFrame: Day -1 , Day 180, Day 360
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: Université d'Auvergne
name: Fabrice Giraudet
role: PRINCIPAL_INVESTIGATOR
References: