Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study
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
- 否
入选标准
- •Will be included as hearing impaired patients:
- •male or female
- •over 18 years of age
- •who are to undergo surgery on the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
- •with a mild to severe sensorineural hearing loss defined by an average hearing loss (average of thresholds obtained at 500, 1000, 2000 and 4000 Hz) greater than 20 dB and less than 90 dB in pure tone bone conduction audiometry on the side of the operated ear.
- •affiliated to a social security system.
- •have read the information note describing the study and have agreed in writing to participate by signing the informed consent form.
- •Will be included as normal hearing patients:
- •male or female
- •over 18 years of age
- •who are to undergo surgery in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
- •free of neuro-sensory deafness, defined by average hearing thresholds less than or equal to 20 dB in tonal bone conduction audiometry on the side of the operated ear
- •affiliated with a social security system.
- •having read the information note describing the study and having agreed in writing to participate by signing the informed consent form.
排除标准
- •Patients for whom the auditory nerve is not accessible during surgery,
- •because of a complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma)
- •because of an anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the posterior face of the rock)
研究组 & 干预措施
Subjects with no hearing loss
干预措施: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode (Procedure)
subjects with hearing loss
干预措施: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode (Procedure)
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 two groups of investigation(66 months)
- Compare the difference of coding of the fine structure(66 months)
- Compare the difference of coding of the temporal envelope(66 months)