NCT03877211已完成不适用
Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Percentage of syllable correctly recognized during speech audiometry test
研究概览
简要总结
The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in French
- •Able to understand written instructions
- •Under French public medical insurance
- •Normal-hearing subjects only:
- •Adult between 18 and 50 years old
- •Without a remarkable otological medical history, for example: chronic otitis, trans-tympanic tubes and / or all ear surgeries;
- •Clear auditory canal and normal eardrum;
- •Average audiometric loss under 20 decibels Hearing Level (dB HL)
- •Cochlear implant users only:
- •Adult between 18 and 60 yo
- •Normal middle ear
- •Used the cochlear implant for more than a year
- •Wearing a device from the company Neurelec/Oticon Medical
排除标准
- •Behavioral and/or neurological disorders
- •Proven psychological disorder
- •Use of psychotropic medication
- •People who experience migraine attacks on a regular basis
- •Use of ototoxic medication
- •Exposed to loud noises within the last 72 hours
- •Included in another clinical trial that uses medication
结局指标
主要结局
Percentage of syllable correctly recognized during speech audiometry test
时间窗: At inclusion
Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.
次要结局
- Sound masking threshold(At inclusion)
- Electrically-evoked Auditory Brainstem Response (eABR)(Up to 12 months after inclusion)
研究者
研究点 (2)
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