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Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02323256
Acronym
NEUROSYLLABIC
Enrollment
91
Registered
2014-12-23
Start date
2014-07-31
Completion date
2018-05-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness

Keywords

cochlear implant, deafness, audiometry, speech perception, severe to profound deafness restored with cochlear implantation

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.

Interventions

OTHERAuditory steady-state response ASSR

comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities

OTHERSpeech-ABR
OTHERAcoustic Change Complex ACC

comparison of ACC complex in response to changes within speech stimulation

OTHERP1-N1-P2 complex and Mismatch Negativity MMN

comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amplitude of auditory steady state responses ASSRone year at least after CI activation
Spectro-temporal analysis of speech-ABRone year at least after CI activation
Acoustic Change Complex ACCone year at least after CI activationAmplitudes and latencies of ACC
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMNone year at least after CI activation
Evolution of amplitude of auditory steady state responses ASSR1 month, 3 months, 6 months, 9 months and 12 months after CI activationEvolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
Evolution of spectro-temporal analysis of speech-ABR1 month, 3 months, 6 months, 9 months and 12 months after CI activationEvolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026