Electrophysiological-based Estimation of Cochlear Implant Fitting

Cochlear Implants Clinical Trial

— ENPICME  

Official title:

Estimation of Perceptual Levels Used in Cochlear Implant Fitting Based on Electrophysiological Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748915
• Other study ID #: 69HCL15_0309
• Status: Completed
• Phase: N/A
• Start date: January 26, 2016
• Est. completion date: June 4, 2020

Study information

• Verified date: September 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implants
• Seizures

Intervention

Other:
• Electrophysiological and psychoacoustic tests

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Service ORL Pavillon U	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ECAP threshold	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 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.	9 months after cochlear implant activation
Secondary	ECAP maximal amplitude	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP maximal amplitudes (in µV) 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 amplitude recorded with and without acoustic stimulations will be compared in patients using EAS devices.	from 11 months after cochlear implant activation
Secondary	ECAP maximal amplitude	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP maximal amplitudes (in µV) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	ECAP latency	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP latencies (in µs) of the ECAP recorded with the highest stimulation level will be determine , 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 latencies recorded with and without acoustic stimulations will be compared in patients using EAS devices.	from 11 months after cochlear implant activation
Secondary	ECAP latency	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP latencies (in µs) of the ECAP recorded with the highest stimulation level will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	ECAP AGF slope	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP AGF slopes (µV/qu) 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 AGF slopes recorded with and without acoustic stimulations will be compared in patients using EAS devices.	from 11 months after cochlear implant activation
Secondary	ECAP AGF slope	ECAP AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. ECAP AGF slopes (µV/qu) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	EABR wave V maximal amplitude	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V maximal amplitudes (µV) 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 EABR AGF recorded in clinical routine/during control visit before these 11 months.	from 11 months after cochlear implant activation
Secondary	EABR wave V maximal amplitude	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V maximal amplitudes (µV) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	EABR wave V latency	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V latencies (ms) recorded with the highest stimulation level 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 EABR AGF recorded in clinical routine/during control visit before these 11 months.	from 11 months after cochlear implant activation
Secondary	EABR wave V latency	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V latencies (ms) recorded with the highest stimulation level will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	EABR wave V threshold	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V thresholds (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 EABR AGF recorded in clinical routine/during control visit before these 11 months.	from 11 months after cochlear implant activation
Secondary	EABR wave V threshold	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V thresholds (current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	EABR wave V AGF slope	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. EABR wave V AGF slopes (µV/qu) 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 EABR AGF recorded in clinical routine/during control visit before these 11 months.	from 11 months after cochlear implant activation
Secondary	EABR wave V AGF slope	EABR AGF will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for 9 months. EABR wave V AGF slopes (µV/qu) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed.	9 months after cochlear implant activation
Secondary	EABR binaural interaction component (BIC)	In bilaterally implanted patients using both of their implants for more than 11 months, EABR BIC will be recorded with a reference electrode of either the older implant or the one associated with the best hearing performances and all the electrodes of the second implant. EABR BIC amplitude (µV) will be determined, compared according to the electrode pairing and correlation tests with the other measures will be performed.	from 11 months after cochlear implant activation
Secondary	Most Comfort Level (MCL)	The MCL (current unit) will be evaluated for each electrode/cochlear site tested during the same recording session than the ECAP threshold evaluated after 11 months. These subjective limits will be compared according to the stimulation sites and correlated to ECAP and/or EABR characteristics.	from 11 months after cochlear implant activation
Secondary	Most Comfort Level (MCL)	The MCL (current unit) will be evaluated for each electrode/cochlear site tested during the same recording session than the ECAP threshold evaluated at 9 months. These subjective limits will be compared according to the stimulation sites and correlated to ECAP and/or EABR characteristics.	9 months after implant cochlear implant activation
Secondary	Speech recognition score	The percentage of speech recognition will be measured at 60 decibels (dB) in open space with implant(s) well fitted during the same recording session than the ECAP threshold evaluated after 11 months. This performance level will be correlated to the ECAP and/or EABR characteristics. In the bimodal and binaural groups, performances will be compared between hearing conditions (monaural = 1 implant vs. bimodal or binaural hearing).; During these audiometry tests, the recognition score will be also measured at 40 and 50 dB and a pure tone audiometry will be performed.	from 11 months after implant cochlear implant activation
Secondary	Speech recognition score	The percentage of speech recognition will be measured at 60 dB in open space with implant(s) well fitted during the same recording session than the ECAP threshold evaluated at 9 months. This performance level will be correlated to the ECAP and/or EABR characteristics.; During these audiometry tests, the recognition score will be also measured at 40 and 50 dB and a pure tone audiometry will be performed.	9 months after implant cochlear implant activation