NCT04198909

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

7 years

First QC Date

November 28, 2019

Last Update Submit

August 8, 2023

Conditions

Healthy VolunteerWithout Hearing Disorders

Keywords

hidden hearing lossquestionnairehearing screeningelectrocochleography

Outcome Measures

Primary Outcomes (2)

  • Latency of wave I by electrocochleography

    The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)

    Day 180

  • Latency of wave I by electrocochleography

    The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)

    Day 360

Secondary Outcomes (2)

  • Hearing thresholds in decibels

    Day -1 , Day 180, Day 360

  • Acoustic reflex thresholds in decibels

    Day -1 , Day 180, Day 360

Study Arms (1)

Cohort 1

EXPERIMENTAL
Diagnostic Test: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways

Interventions

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

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

Cohort 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Hidden

Interventions

Audiometry, Evoked Response

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Fabrice Giraudet

    Université d'Auvergne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 13, 2019

Study Start

April 29, 2019

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

FR(1)