Clinical trial NCT02323256: Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
Official title: Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Keywords: cochlear implant
deafness
audiometry
speech perception
severe to profound deafness restored with cochlear implantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 91
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Amplitude of auditory steady state responses ASSR
timeFrame: one year at least after CI activation
measure: Spectro-temporal analysis of speech-ABR
timeFrame: one year at least after CI activation
measure: Acoustic Change Complex ACC
timeFrame: one year at least after CI activation
measure: amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
timeFrame: one year at least after CI activation
measure: Evolution of amplitude of auditory steady state responses ASSR
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
measure: Evolution of spectro-temporal analysis of speech-ABR
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
measure: Acoustic Change Complex ACC
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
measure: amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital Edouard Herriot
Study officials:
References: