Clinical trial NCT02748915: Electrophysiological-based Estimation of Cochlear Implant Fitting
Official title: Estimation of Perceptual Levels Used in Cochlear Implant Fitting Based on Electrophysiological Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implants
Keywords: Cochlear Implant
ECAP
EABR
perceptual levels
hearing performances
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: ECAP threshold
timeFrame: from 11 months after cochlear implant activation
Secondary outcomes:
measure: ECAP threshold
timeFrame: 9 months after cochlear implant activation
measure: ECAP maximal amplitude
timeFrame: from 11 months after cochlear implant activation
measure: ECAP maximal amplitude
timeFrame: 9 months after cochlear implant activation
measure: ECAP latency
timeFrame: from 11 months after cochlear implant activation
measure: ECAP latency
timeFrame: 9 months after cochlear implant activation
measure: ECAP AGF slope
timeFrame: from 11 months after cochlear implant activation
measure: ECAP AGF slope
timeFrame: 9 months after cochlear implant activation
measure: EABR wave V maximal amplitude
timeFrame: from 11 months after cochlear implant activation
measure: EABR wave V maximal amplitude
timeFrame: 9 months after cochlear implant activation
measure: EABR wave V latency
timeFrame: from 11 months after cochlear implant activation
measure: EABR wave V latency
timeFrame: 9 months after cochlear implant activation
measure: EABR wave V threshold
timeFrame: from 11 months after cochlear implant activation
measure: EABR wave V threshold
timeFrame: 9 months after cochlear implant activation
measure: EABR wave V AGF slope
timeFrame: from 11 months after cochlear implant activation
measure: EABR wave V AGF slope
timeFrame: 9 months after cochlear implant activation
measure: EABR binaural interaction component (BIC)
timeFrame: from 11 months after cochlear implant activation
measure: Most Comfort Level (MCL)
timeFrame: from 11 months after cochlear implant activation
measure: Most Comfort Level (MCL)
timeFrame: 9 months after implant cochlear implant activation
measure: Speech recognition score
timeFrame: from 11 months after implant cochlear implant activation
measure: Speech recognition score
timeFrame: 9 months after implant cochlear implant activation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Service ORL Pavillon U
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric TRUY, Professor
role: PRINCIPAL_INVESTIGATOR
References: