Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Spectro-temporal analysis of speech-ABR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
newly cochlear implanted adult patients
longitudinal group
干预措施: Speech-ABR (Other)
newly cochlear implanted adult patients
longitudinal group
干预措施: Auditory steady-state response ASSR (Other)
newly cochlear implanted adult patients
longitudinal group
干预措施: Acoustic Change Complex ACC (Other)
newly cochlear implanted adult patients
longitudinal group
干预措施: P1-N1-P2 complex and Mismatch Negativity MMN (Other)
newly cochlear implanted children
longitudinal group
干预措施: Auditory steady-state response ASSR (Other)
newly cochlear implanted children
longitudinal group
干预措施: Speech-ABR (Other)
newly cochlear implanted children
longitudinal group
干预措施: Acoustic Change Complex ACC (Other)
newly cochlear implanted children
longitudinal group
干预措施: P1-N1-P2 complex and Mismatch Negativity MMN (Other)
cochlear implanted adult patients (CI>1 year)
transversal group
干预措施: Auditory steady-state response ASSR (Other)
cochlear implanted adult patients (CI>1 year)
transversal group
干预措施: Speech-ABR (Other)
cochlear implanted adult patients (CI>1 year)
transversal group
干预措施: Acoustic Change Complex ACC (Other)
cochlear implanted adult patients (CI>1 year)
transversal group
干预措施: P1-N1-P2 complex and Mismatch Negativity MMN (Other)
normal hearing adult subjects
transversal group
干预措施: Speech-ABR (Other)
normal hearing adult subjects
transversal group
干预措施: Auditory steady-state response ASSR (Other)
normal hearing adult subjects
transversal group
干预措施: Acoustic Change Complex ACC (Other)
normal hearing adult subjects
transversal group
干预措施: P1-N1-P2 complex and Mismatch Negativity MMN (Other)
结局指标
主要结局
Spectro-temporal analysis of speech-ABR
时间窗: one year at least after CI activation
Evolution of spectro-temporal analysis of speech-ABR
时间窗: 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
时间窗: 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
时间窗: 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
Amplitude of auditory steady state responses ASSR
时间窗: one year at least after CI activation
Acoustic Change Complex ACC
时间窗: 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
Acoustic Change Complex ACC
时间窗: one year at least after CI activation
Amplitudes and latencies of ACC
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
时间窗: one year at least after CI activation
次要结局
未报告次要终点