Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT04198909

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

Led by University Hospital, Clermont-Ferrand · Updated on 2023-08-09

430

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Clermont-Ferrand

Lead Sponsor

L

Laboratory of Neurosensory Biophysics - UMR INSERM 1107.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 55 years old
  • Affiliated to a social security system
  • Understand spoken and written French
  • Normal hearing with normal tympanogram and audiogram
Not Eligible

You will not qualify if you...

  • Complaint of hearing problems
  • Exposure to loud noise professionally or through activities
  • Refusal to participate in the study
  • Ear infections or ear, nose, and throat medical history
  • Cardiovascular, metabolic, neurological, or psychiatric diseases
  • Being a protected person
  • Healthy volunteers who have received compensation of 4500ac or more in clinical studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chu Clermont Ferrand

Clermont-Ferrand, France, 63003

Actively Recruiting

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Research Team

L

Lise Laclautre

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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