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

NCT04198909 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer
  • Without Hearing Disorders

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

  • Laboratory of Neurosensory Biophysics - UMR INSERM 1107.

    collaborator UNKNOWN

  • Foundation of Gueules Cassées

    collaborator UNKNOWN

  • Region of Auvergne-Rhône-Alpes

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Fabrice Giraudet · Université d'Auvergne

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198909 on ClinicalTrials.gov