RecruitingNot ApplicableNCT04198909

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

430 participants

Start Date

Apr 29, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

DIAGNOSTIC_TESTElectrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways

Electrocochleography is a technique that analyses the functionality of inner ear.


Locations(1)

Chu Clermont Ferrand

Clermont-Ferrand, France

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NCT04198909


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