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

Primary Purpose

Healthy Volunteer, Without Hearing Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy Volunteer focused on measuring hidden hearing loss, questionnaire, hearing screening, electrocochleography

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 18 and 25 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

Sites / Locations

  • Chu Clermont FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort 1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 28, 2019
Last Updated
August 8, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratory of Neurosensory Biophysics - UMR INSERM 1107., Foundation of Gueules Cassées, Region of Auvergne-Rhône-Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT04198909
Brief Title
Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
Acronym
ECOG
Official Title
Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratory of Neurosensory Biophysics - UMR INSERM 1107., Foundation of Gueules Cassées, Region of Auvergne-Rhône-Alpes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteer, Without Hearing Disorders
Keywords
hidden hearing loss, questionnaire, hearing screening, electrocochleography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways
Intervention Description
Electrocochleography is a technique that analyses the functionality of inner ear.
Primary Outcome Measure Information:
Title
Latency of wave I by electrocochleography
Description
The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)
Time Frame
Day 180
Title
Latency of wave I by electrocochleography
Description
The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)
Time Frame
Day 360
Secondary Outcome Measure Information:
Title
Hearing thresholds in decibels
Description
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
Title
Acoustic reflex thresholds in decibels
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Giraudet
Organizational Affiliation
Université d'Auvergne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Fabrice Giraudet

12. IPD Sharing Statement

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

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