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

Not Applicable

• Conditions: Hearing Loss
• Interventions: Other: Electrophysiological study of the interindividual variability of vocal performance

• Registration Number: NCT01805167
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Study First Posted: 2013-03-06
• Last Update Posted: 2013-03-06
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subjects with a cochlear implant	Electrophysiological study of the interindividual variability of vocal performance	-

Primary Outcome Measures

Name	Time	Method
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.	At the inclusion - Day 0	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)

Secondary Outcome Measures

Name	Time	Method
Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance	At the inclusion - Day 0	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.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France