Healthy VolunteerECOGNCT04198909
Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
A study testing Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways in people with Healthy Volunteer and Without Hearing Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Without Hearing Disorders
- What is being tested?
- Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2019to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Fabrice Giraudet
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteer, Without Hearing Disorders
- Being tested
- Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways
- Keywords
- hidden hearing loss, questionnaire, hearing screening, electrocochleography
- Medical subject headings
- Hearing Loss, Hidden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathwaysDiagnostic test
Electrocochleography is a technique that analyses the functionality of inner ear.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Diagnostic Test: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency of wave I by electrocochleography
The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)
Measured: 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)
Measured: Day 360
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day -1 , Day 180, Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start29 Apr 2019
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory of Neurosensory Biophysics - UMR INSERM 1107., Foundation of Gueules Cassées, Region of Auvergne-Rhône-Alpes
- Responsible party
- Sponsor
- Investigators
- Fabrice Giraudet, Principal investigator, Université d'Auvergne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198909
- Sponsor's protocol ID
- RBHP 2018 GIRAUDET
- Other IDs
- 2018-A02525-50
- Acronym
- ECOG
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
- ClinicalTrials.gov ID
- NCT04198909
- Acronym / sponsor ID
- ECOG / RBHP 2018 GIRAUDET
- Conditions
- Healthy Volunteer, Without Hearing Disorders
- Keywords
- hidden hearing loss, questionnaire, hearing screening, electrocochleography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratory of Neurosensory Biophysics - UMR INSERM 1107., Foundation of Gueules Cassées, Region of Auvergne-Rhône-Alpes
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Diagnostic Test: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathwaysElectrocochleography is a technique that analyses the functionality of inner ear. | Diagnostic test | Cohort 1 |
Primary outcome
Latency of wave I by electrocochleography
Time frame: Day 180
The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)
Latency of wave I by electrocochleography
Time frame: Day 360
The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)
2 secondary outcomes
Hearing thresholds in decibels
Time frame: Day -1 , Day 180, Day 360
Acoustic reflex thresholds in decibels
Time frame: Day -1 , Day 180, Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice Giraudet principal investigator
Université d'Auvergne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways in people with Healthy Volunteer and Without Hearing Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency of wave I by electrocochleography (time frame: Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.