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Clinical Trials/NCT01805167
NCT01805167
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country20 target enrollmentFebruary 2013
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
20
Locations
1
Primary Endpoint
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Study Sites (1)

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