跳至主要内容
临床试验/NCT06499584
NCT06499584招募中不适用

The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain

CHU de Reims1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月21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
20
试验地点
1
主要终点
To compare the amplitude of coding of complex and ecological sounds

研究概览

简要总结

In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound. Depending on the stimulus, the fine structure and temporal envelope of the signal will vary, allowing us to determine its characteristics. By phenotyping patients before surgery using subjective and objective audiometric tests, it will be possible to isolate for each patient the moment when the fine structure disappears and when the temporal envelope is effective.

详细描述

During functional cerebellopontine angle surgery, a spherical electrode is placed on the human cochlear nerve to monitor hearing. Once the electrode is in place, clicks and speech signals with and without noise are delivered to analyze the cochlear electrophysiological signal produced. Depending on the characteristics recorded, this signal can be used to determine how fine structure and temporal envelope are encoded by the cochlea. Prior to surgery, each patient is evaluated by an audiologist to determine quiet and noise thresholds, tone and speech, electrocochleography, distortion testing, tympanometry, ABR and psychoacoustic testing.

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 80 Years(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

To compare the amplitude of coding of complex and ecological sounds

时间窗: At 48 months

The goal is to compare the amplitude of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests.

To compare the spectrum of coding of complex and ecological sounds

时间窗: At 48 months

The goal is to compare the spectrum of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests.

次要结局

  • The amplitude of the temporal envelope of the(at 48 months)
  • The amplitude of the fine structure of the signal(at 48 months)
  • The spectrum of the temporal envelope of the signal(At 48 months)
  • The spectrum of the fine structure of the signal(at 48 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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