NCT03552224

Brief Summary

To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 11, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2021

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

3 years

First QC Date

May 23, 2018

Last Update Submit

December 29, 2021

Conditions

Hearing Loss

Keywords

Evoked auditory nerve activityHearing LossTinnitus

Outcome Measures

Primary Outcomes (2)

  • Amplitude of global evoked auditory nerve activity

    36 months

  • Spectrum of global evoked auditory nerve activity

    36 months

Secondary Outcomes (1)

  • Mesure of peristimulus time responses of evoked auditory nerve activity

    36 months

Study Arms (2)

Subjects with no hearing loss

EXPERIMENTAL

Subjects referred for cerebellopontine angle surgery with no hearing loss with recording of auditory nerve activity by contact electrode

Procedure: Recording of auditory nerve activity

Subjects with hearing loss

EXPERIMENTAL

Subjects referred for cerebellopontine angle surgery with hearing loss with recording of auditory nerve activity by contact electrode

Procedure: Recording of auditory nerve activity

Interventions

Recording of auditory nerve activityPROCEDURE

near field recording of auditory nerve activity with contact electrode

Subjects with hearing lossSubjects with no hearing loss

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years ( inclusive borders)
  • patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and
  • Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or
  • Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2).
  • Voluntary subjects to participate in the study,
  • Subjects having signed written consent to participate in the study,
  • Easily accessible topics.

You may not qualify if:

  • Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator,
  • Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed,
  • Subjects for whom there is a contraindication to general anesthesia,
  • Subjects with a central neurological pathology that can disrupt electrophysiological recordings
  • Not affiliated to a French social security scheme or not benefiting from such a scheme,
  • Majors protected by law,
  • Pregnant women,
  • deprived of liberty by judicial or administrative decision,
  • Infectious or inflammatory pathology of the middle ear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Hearing LossTinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Frédéric VENAIL, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 11, 2018

Study Start

July 11, 2018

Primary Completion

June 26, 2021

Study Completion

June 26, 2021

Last Updated

December 30, 2021

Record last verified: 2021-12

Locations

FR(1)