跳至主要内容
临床试验/NCT06490237
NCT06490237招募中不适用

Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study

CHU de Reims1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
CHU de Reims
入组人数
60
试验地点
1
主要终点
Compare the amplitude of global evoked auditory nerve activity

研究概览

简要总结

The fine evaluation of the function of auditory neurons in silence and in noise in humans is difficult, if not impossible, to date with the conventional methods available. That is why in certain situations, the hearing aids of patient with hearing loss fail, especially in the presence of noise.

In this study the investigators aim at investigating the global spontaneous and sound evoked human auditory nerve activity from electrophysiological acquisitions performed directly on the cochlear nerve in patients requiring posterior fossa surgery.

详细描述

The fine evaluation of the function of auditory neurons in silence and in noise in humans is difficult, if not impossible, to date with the conventional methods available. That is why in certain situations, the hearing aids of patient with hearing loss fail, especially in the presence of noise.

In this study the investigators aim at investigating the global spontaneous and sound evoked human auditory nerve activity from electrophysiological acquisitions performed directly on the cochlear nerve in patients requiring posterior fossa surgery.

Stimulations will be performed in silence and in noise from stimuli identical to those used during the preoperative auditory assessment: clic and speech syllable stimulation. These acquisitions will allow us to compare clinical and electrophysiological data in order to better understand the coding of hearing in normal and hearing loss humans under silent and noisy conditions. A prospective longitudinal study will be performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Compare the amplitude of global evoked auditory nerve activity

时间窗: 66 months

Compare the amplitude and spectrum of global evoked auditory nerve activity in silence and in noise with basic and speech stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests.

Compare the spectrum of global evoked auditory nerve activity

时间窗: 66 months

Compare the spectrum of global evoked auditory nerve activity in silence and in noise with basic and speech stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests

次要结局

  • Compare the difference of coding of the fine structure(66 months)
  • Compare the difference of coding of the temporal envelope(66 months)
  • Compare the two groups of investigation(66 months)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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