Optimizing a non-invasive method to study auditory nerve function
Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
This study is testing a new way to measure how well the auditory nerve works in healthy people to help find hidden hearing loss that regular tests might miss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT04198909 on ClinicalTrials.gov |
What this trial studies
This study aims to optimize a non-invasive electrophysiological method, specifically electrocochleography, to assess the functionality of auditory nerve fibers in healthy volunteers. The research focuses on understanding 'hidden hearing loss,' which may not be detected by conventional hearing tests. By refining the electrode assembly and acoustic stimulation techniques, the study seeks to establish normative values for wave I morphology in individuals without hearing disorders. This could lead to better diagnostic tools for identifying auditory nerve injuries.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers aged 18 to 55 with normal hearing and no history of ear infections or noise exposure.
Not a fit: Patients with existing hearing complaints, ear infections, or significant medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive diagnostic tool for early detection of auditory nerve damage, improving patient outcomes.
How similar studies have performed: While the approach of using non-invasive electrocochleography is innovative, similar studies have shown promise in assessing auditory function, though this specific optimization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand
- Chu Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Fabrice Giraudet — Université d'Auvergne
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.