NCT04198909 Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
| NCT ID | NCT04198909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2019-04-29 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2019-04-29 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Fabrice Giraudet
PRINCIPAL INVESTIGATOR
Université d'Auvergne
Frequently Asked Questions
Who can join the NCT04198909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04198909 currently recruiting?
Yes, NCT04198909 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT04198909 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT04198909 clinical trial?
NCT04198909 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Fabrice Giraudet at Université d'Auvergne. The trial plans to enroll 220 participants.