Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

Not Applicable

Completed

• Conditions: Deafness
• Interventions: Other: Auditory steady-state response ASSR; Other: Speech-ABR; Other: Acoustic Change Complex ACC; Other: P1-N1-P2 complex and Mismatch Negativity MMN

• Registration Number: NCT02323256
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• native French speaker
• no medical treatment for behavior or neurological disorders
• normal or corrected vision
• right-handed
• normal ORL examination
• valid affiliation to social security
• absence of participation to another study

For the cochlear implanted patients:

• aged from 1 to 70
• bilateral severe to profound deafness
• cochlear implant
• congenital deafness, pre or post lingual

For the normal-hearing subjects:

• Aged from 18 to 70
• Normal tonal audiometry

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Exclusion Criteria

• No signed consent
• Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease
• Physical health deficiency
• Mental retardation
• Neurological or psychiatric disease incompatible with the testing procedure
• Schooling in a foreign language
• Foreign language spoken at home with both parents
• Invalid social security
• For the normal hearing subjects, no known hearing deficits

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
newly cochlear implanted adult patients	Auditory steady-state response ASSR	longitudinal group
cochlear implanted adult patients (CI>1 year)	Auditory steady-state response ASSR	transversal group
newly cochlear implanted children	Auditory steady-state response ASSR	longitudinal group
newly cochlear implanted adult patients	Acoustic Change Complex ACC	longitudinal group
cochlear implanted adult patients (CI>1 year)	Acoustic Change Complex ACC	transversal group
normal hearing adult subjects	Acoustic Change Complex ACC	transversal group
newly cochlear implanted children	Acoustic Change Complex ACC	longitudinal group
newly cochlear implanted adult patients	P1-N1-P2 complex and Mismatch Negativity MMN	longitudinal group
newly cochlear implanted children	Speech-ABR	longitudinal group
newly cochlear implanted adult patients	Speech-ABR	longitudinal group
newly cochlear implanted children	P1-N1-P2 complex and Mismatch Negativity MMN	longitudinal group
cochlear implanted adult patients (CI>1 year)	Speech-ABR	transversal group
cochlear implanted adult patients (CI>1 year)	P1-N1-P2 complex and Mismatch Negativity MMN	transversal group
normal hearing adult subjects	Auditory steady-state response ASSR	transversal group
normal hearing adult subjects	Speech-ABR	transversal group
normal hearing adult subjects	P1-N1-P2 complex and Mismatch Negativity MMN	transversal group

Primary Outcome Measures

Name	Time	Method
Spectro-temporal analysis of speech-ABR	one year at least after CI activation
Evolution of spectro-temporal analysis of speech-ABR	1 month, 3 months, 6 months, 9 months and 12 months after CI activation	Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
Evolution of amplitude of auditory steady state responses ASSR	1 month, 3 months, 6 months, 9 months and 12 months after CI activation	Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN	1 month, 3 months, 6 months, 9 months and 12 months after CI activation	Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients
Acoustic Change Complex ACC	1 month, 3 months, 6 months, 9 months and 12 months after CI activation	Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
Amplitude of auditory steady state responses ASSR	one year at least after CI activation

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital Edouard Herriot; 🇫🇷 Lyon, France