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临床试验/NCT01805167
NCT01805167已完成不适用

Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.

研究概览

简要总结

Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject of French language
  • Subject with a moderate bilateral sensorineural hearing loss, severe to profound
  • Sensorineural hearing loss post-lingual (after onset of language acquisition)
  • Subject paired with the implant Neurelec (Appendix 1) for more than 9 months
  • Subject has received an appropriate setting under usual clinical follow-up
  • Elderly 18 to 75 years
  • Subject giving consent

排除标准

  • Sensorineural hearing loss pre-lingual
  • Deafness following a meningitis, or neurodegenerative diseases
  • Illiteracy
  • Pregnant women
  • Subject blind
  • Subject enjoying a measure of legal protection
  • Subject incapable of giving consent
  • Subject vulnerable

研究组 & 干预措施

subjects with a cochlear implant

Other

干预措施: Electrophysiological study of the interindividual variability of vocal performance (Other)

结局指标

主要结局

Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.

时间窗: At the inclusion - Day 0

The vocal performance will be noted in percentage of voice recognition in the silence and in the noise. And the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13)

次要结局

  • Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance(At the inclusion - Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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