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

Primary Purpose

Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrophysiological study of the interindividual variability of vocal performance
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss focused on measuring Subject with cochlear implant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

subjects with a cochlear implant

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
February 22, 2013
Last Updated
March 5, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01805167
Brief Title
Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
Official Title
Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Subject with cochlear implant

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subjects with a cochlear implant
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Electrophysiological study of the interindividual variability of vocal performance
Primary Outcome Measure Information:
Title
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.
Description
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)
Time Frame
At the inclusion - Day 0
Secondary Outcome Measure Information:
Title
Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance
Description
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.
Time Frame
At the inclusion - Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GUEVARA, Dr
Email
guevara.n@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Guevara, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GUEVARA, Dr
Email
guevara.n@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Guevara, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
27149268
Citation
Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.
Results Reference
derived

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

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