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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer; Without Hearing Disorders
• Intervention / Treatment: Diagnostic test: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways

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.

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont Ferrand
    • Principal Investigator: Fabrice Giraudet
    • Contact: Lise Laclautre; Email: promo_interne_drci@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	Diagnostic test: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways; Electrocochleography is a technique that analyses the functionality of inner ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency of wave I by electrocochleography	The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)	Day 180
Latency of wave I by electrocochleography	The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)	Day 360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day -1 , Day 180, Day 360
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.	Day -1 , Day 180, Day 360

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Laboratory of Neurosensory Biophysics - UMR INSERM 1107.; Foundation of Gueules Cassées; Region of Auvergne-Rhône-Alpes
• Investigators: Principal Investigator: Fabrice Giraudet, Université d'Auvergne

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: questionnaire; hidden hearing loss; hearing screening; electrocochleography
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders
• Other Study ID Numbers: RBHP 2018 GIRAUDET; 2018-A02525-50 (Other Identifier: 2018-A02525-50)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No