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

NCT ID: NCT01805167

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

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.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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subjects with a cochlear implant

Group Type OTHER

Electrophysiological study of the interindividual variability of vocal performance

Intervention Type OTHER

Interventions

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Electrophysiological study of the interindividual variability of vocal performance

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Guevara, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas GUEVARA, Dr

Role: CONTACT

Facility Contacts

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Nicolas GUEVARA, Dr

Role: primary

References

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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.

Reference Type DERIVED
PMID: 27149268 (View on PubMed)

Other Identifiers

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2012-A01374-39

Identifier Type: OTHER

Identifier Source: secondary_id

12-AOI-06

Identifier Type: -

Identifier Source: org_study_id

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