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Electrophysiological-based Estimation of Cochlear Implant Fitting

NCT ID: NCT02748915

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-26

Study Completion Date

2020-06-04

Brief Summary

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The primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (CI) adult users to and to estimate predictive models of their fitting parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. In a second group of experienced users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12 months or more of use. Correlation analyzes with demographic data, performance and fitting parameters will be performed as well. Statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis.

The secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and compared in the different conditions.

Detailed Description

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Conditions

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Cochlear Implants

Keywords

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Cochlear Implant ECAP EABR perceptual levels hearing performances

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients using cochlear implants

All patients using cochlear implants included in the study will take electrophysiological and psychoacoustic tests to measure auditive parameters regarding the study objectives : ECAP, EABR, speech recognition and MCL.

Group Type EXPERIMENTAL

Electrophysiological and psychoacoustic tests

Intervention Type OTHER

Patients using EAS device

Patients using EAS device for more than 11 months will take electrophysiological and psychoacoustic tests with the implant functioning only with electrical pulses or in bimodal mode to measure ECAP, EABR, speech recognition and MCL ; this will allow to perform bimodal comparison.

Group Type EXPERIMENTAL

Electrophysiological and psychoacoustic tests

Intervention Type OTHER

Patients with bilateral cochlear implant

Patients with bilateral cochlear implant for more than 11 months will take electrophysiological and psychoacoustic tests to measure ECAP, EABR, speech recognition, and MCL. The binaural interaction component will also be measured ; this will allow to perform binaural comparison.

Group Type EXPERIMENTAL

Electrophysiological and psychoacoustic tests

Intervention Type OTHER

Interventions

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Electrophysiological and psychoacoustic tests

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Good general health status including no neuropsychological diseases affecting intellectual capacities
* Users of cochlear implant or electro-acoustic stimulation devices
* Normal otoscopy
* No excessive sound exposure within 48h before the measure

Exclusion Criteria

* For women, possibility of pregnancy (absence of effective contraception or confirmed menopause);
* Concomitant use of ototoxic or psychotropic treatment with anxiolytic and / or antipsychotic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric TRUY, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Edouard Herriot - Service ORL Pavillon U

Lyon, , France

Site Status

Countries

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France

References

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Joly CA, Reynard P, Hermann R, Seldran F, Gallego S, Idriss S, Thai-Van H. Intra-Cochlear Current Spread Correlates with Speech Perception in Experienced Adult Cochlear Implant Users. J Clin Med. 2021 Dec 13;10(24):5819. doi: 10.3390/jcm10245819.

Reference Type RESULT
PMID: 34945115 (View on PubMed)

Joly CA, Pean V, Hermann R, Seldran F, Thai-Van H, Truy E. Using Electrically-evoked Compound Action Potentials to Estimate Perceptive Levels in Experienced Adult Cochlear Implant Users. Otol Neurotol. 2017 Oct;38(9):1278-1289. doi: 10.1097/MAO.0000000000001548.

Reference Type RESULT
PMID: 28834942 (View on PubMed)

Other Identifiers

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69HCL15_0309

Identifier Type: -

Identifier Source: org_study_id