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NCT04198909
Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
Conditions: Healthy Volunteer, Without Hearing Disorders
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 220
Sponsor: University Hospital, Clermont-Ferrand
Location: Chu Clermont Ferrand Clermont-Ferrand
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
Source: ClinicalTrials.gov (NCT04198909). StuddyBuddy aggregates publicly available trial information.