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

March 5, 2013 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Recruiting
        • Chu de Nice
        • Contact:
        • Principal Investigator:
          • Nicolas Guevara, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: 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)
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
Time Frame: 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.
At the inclusion - Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Nicolas GUEVARA, Dr, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-AOI-06
  • 2012-A01374-39 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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