Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
NEUROSYLLABIC
Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
2 other identifiers
interventional
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedAugust 11, 2025
August 1, 2025
3.8 years
October 15, 2014
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Amplitude of auditory steady state responses ASSR
one year at least after CI activation
Spectro-temporal analysis of speech-ABR
one year at least after CI activation
Acoustic Change Complex ACC
Amplitudes and latencies of ACC
one year at least after CI activation
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
one year at least after CI activation
Evolution of amplitude of auditory steady state responses ASSR
Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of spectro-temporal analysis of speech-ABR
Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Acoustic Change Complex ACC
Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
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
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Study Arms (4)
newly cochlear implanted adult patients
EXPERIMENTALlongitudinal group
newly cochlear implanted children
EXPERIMENTALlongitudinal group
cochlear implanted adult patients (CI>1 year)
ACTIVE COMPARATORtransversal group
normal hearing adult subjects
ACTIVE COMPARATORtransversal group
Interventions
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
comparison of ACC complex in response to changes within speech stimulation
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon - Hopital Edouard Herriot
Lyon, 69003, France
Related Publications (1)
Attina V, Mina F, Stahl P, Duroc Y, Veuillet E, Truy E, Thai-Van H. A New Method to Test the Efficiency of Cochlear Implant Artifacts Removal From Auditory Evoked Potentials. IEEE Trans Neural Syst Rehabil Eng. 2017 Dec;25(12):2453-2460. doi: 10.1109/TNSRE.2017.2723952. Epub 2017 Jul 6.
PMID: 28692981RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2014
First Posted
December 23, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
August 11, 2025
Record last verified: 2025-08