Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Study Overview
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Brief Summary
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Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.

Official Title
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Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Conditions
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Hearing Loss

Intervention / Treatment
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* Other: Electrophysiological study of the interindividual variability of vocal performance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject of French language Subject with a moderate bilateral sensorineural hearing loss, severe to profound Sensorineural hearing loss post-lingual (after onset of language acquisition) Subject paired with the implant Neurelec (Appendix 1) for more than 9 months Subject has received an appropriate setting under usual clinical follow-up Elderly 18 to 75 years Subject giving consent Exclusion Criteria: Sensorineural hearing loss pre-lingual Deafness following a meningitis, or neurodegenerative diseases Illiteracy Pregnant women Subject blind Subject enjoying a measure of legal protection Subject incapable of giving consent Subject vulnerable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: subjects with a cochlear implant<br> | Other: Electrophysiological study of the interindividual variability of vocal performance<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation. | The vocal performance will be noted in percentage of voice recognition in the silence and in the noise. And the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13) | At the inclusion - Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance | Collection of the PEAEP after stimulation of 4 different electrodes distributed on the totality of door-electrode: generally, electrodes 4, 7, 10 and 13 will be stimulated. The amplitudes and the latencies of the waves II, III and V will be analyzed and compared with the vocal performances. | At the inclusion - Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subject with cochlear implant