Electrophysiological-based Estimation of Cochlear Implant Fitting

NCT02748915 | Completed

• 1 other identifier: 69HCL15_0309
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cochlear Implants

Keywords

Cochlear Implant; ECAP; EABR; perceptual levels; hearing performances

Outcome Measures

Primary Outcomes (1)

• ECAP threshold

  ECAP amplitude growth function (AGF) will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP thresholds (in current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to ECAP AGF recorded in clinical routine/during control visit before these 11 months that includes intra-operative records when available. The ECAP threshold recorded with and without acoustic stimulations will be compared in patients using EAS devices.

  from 11 months after cochlear implant activation

Secondary Outcomes (20)

• ECAP threshold

  9 months after cochlear implant activation

• ECAP maximal amplitude

  from 11 months after cochlear implant activation

• ECAP maximal amplitude

  9 months after cochlear implant activation

• ECAP latency

  from 11 months after cochlear implant activation

• ECAP latency

  9 months after cochlear implant activation

Study Arms (3)

Patients using cochlear implants

EXPERIMENTAL

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.

Other: Electrophysiological and psychoacoustic tests

Patients using EAS device

EXPERIMENTAL

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.

Other: Electrophysiological and psychoacoustic tests

Patients with bilateral cochlear implant

EXPERIMENTAL

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.

Other: Electrophysiological and psychoacoustic tests

Interventions

Electrophysiological and psychoacoustic tests OTHER

Patients using EAS device; Patients using cochlear implants; Patients with bilateral cochlear implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot - Service ORL Pavillon U

Lyon, 69437, France

Location

Related Publications (2)

• 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.

  PMID: 34945115 RESULT

• 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.

  PMID: 28834942 RESULT

Study Officials

• Eric TRUY, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 22, 2016
• Study Start: January 26, 2016
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)