Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.
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
研究组 & 干预措施
Cochlear implant users
Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
干预措施: Psychophysical tuning curves in forward masking (Other)
Cochlear implant users
Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
干预措施: Electrically-evoked Auditory Brainstem Response (EABR) (Other)
Cochlear implant users
Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
干预措施: speech audiometry in noise (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
干预措施: speech audiometry in noise (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
干预措施: Psychophysical tuning curves in forward masking (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
干预措施: Tonal audiometry (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
干预措施: Auditory canal examination (Other)
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)