Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline in 3d-D value at day 14
研究概览
简要总结
The construction of our auditory space requires several prerequisites, including localization abilities in 3D (azimuth, elevation and distance). These abilities rely on the proper development and functionality of the auditory system to extract various acoustic cues from our environment. Extraction and analysis of these auditory cues are based on the synchronous use of ears, called binaurality. Other natural behaviours are useful to precisely determine the location of a sound source: visual information and head movements.
The slightest anatomical-functional change (e.g. unilateral hearing loss, malformation of the pinna) can disturb spatial hearing abilities. Many patients with hearing loss are fitted with a hearing aid (HA) or a cochlear implant (CI) to ensure the best speech understanding. However, this auditory rehabilitation remains insufficient to restore a good perception of spatial hearing. One of the key point to improve sound localization seems to be microphone positioning on hearing aids. Several questions remain on the optimal microphone positioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 inclusive
- •Regular follow-up in the Ear Nose and Throat department of the Edouard Herriot hospital in Lyon
- •Post-lingual deafness
- •Fitted with two Advanced Bionics (AB) cochlear implants (Naïda Q70 or Naïda Q90 processor) Or fitted with one AB cochlear implant and a contralateral hearing aid
- •Fitted with the latest implant for more than 1 year
- •Normal or corrected vision
- •Able to understand experimental instructions
- •Affiliated with a social security scheme
排除标准
- •Oculomotor disorder
- •Bilateral vestibular areflexia
- •Adult subject to a legal protection measure (guardianship, curatorship)
研究组 & 干预措施
Implanted patients
All the participants are patients with post-lingual deafness and fitted with cochlear implants
干预措施: Modification of active microphone positioning (Device)
Implanted patients
All the participants are patients with post-lingual deafness and fitted with cochlear implants
干预措施: SPHERE protocol (Behavioral)
Implanted patients
All the participants are patients with post-lingual deafness and fitted with cochlear implants
干预措施: French Matrix Test (Behavioral)
Implanted patients
All the participants are patients with post-lingual deafness and fitted with cochlear implants
干预措施: Quality of life questionnaire (Behavioral)
Implanted patients
All the participants are patients with post-lingual deafness and fitted with cochlear implants
干预措施: Likert scale (Behavioral)
结局指标
主要结局
Change from baseline in 3d-D value at day 14
时间窗: Baseline and day 14
We will compare 3d-D values obtained with baseline microphone position (at day 0) and 1 week after the second microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in SRT values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance.
Change from baseline in SRT value at day 14
时间窗: Baseline and day 14
We will compare SRT values obtained with baseline microphone position (at day 0) and 1 week after the second microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance.
Change from baseline in 3d-D value at day 7
时间窗: Baseline and day 7
We will compare 3d-D values obtained with baseline microphone position (at day 0) and 1 week after the first microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in SRT values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance.
Change from baseline in SRT value at day 7
时间窗: Baseline and day 7
We will compare SRT values obtained with baseline microphone position (at day 0) and 1 week after the first microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance.
Change from baseline in SSQ15 score at day 7
时间窗: Baseline and day 7
We will compare SSQ15 scores obtained with baseline microphone position (at day 0) and 1 week after the first microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SRT values, these results will allow us to assess the effect of microphones positioning on spatial auditory performance.
Change from baseline in SSQ15 score at day 14
时间窗: Baseline and day 14
We will compare SSQ15 scores obtained with baseline microphone position (at day 0) and 1 week after the second microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SRT values, these results will allow us to assess the effect of microphones positioning on spatial auditory performance.
次要结局
未报告次要终点