Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Short term rehabilitation effect on the spatial auditory performance - 4 sessions
研究概览
简要总结
A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Unfortunately, there is currently no suitable postoperative management for these localization problems. However, the discomfort felt by patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible to develop a rehabilitation protocol adapted to each patient. This project will focus on the evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory (auditory and visual) feedback, for bilateral CI adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 between 18 and 75 years inclusive
- •Use of the second CI for at least 1 year
- •Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in Lyon
- •Post-lingual deafness
- •Average voice recognition over 80% with 2 Cochlear Implants
- •Normal vision (with or without correction)
- •Able to understand the experimental instructions
- •Affiliated to a social security scheme
排除标准
- •Oculomotor disorder
- •Bilateral vestibular areflexia
研究组 & 干预措施
visual-auditory feedback
Patients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: Rehabilitation protocol with visual-auditory feedback (Behavioral)
visual-auditory feedback
Patients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: SPHERE protocol (Behavioral)
visual-auditory feedback
Patients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: French Matrix Test (Behavioral)
visual-auditory feedback
Patients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire (Behavioral)
visual feedback
Patients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: Rehabilitation protocol with visual feedback (Behavioral)
visual feedback
Patients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: SPHERE protocol (Behavioral)
visual feedback
Patients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: French Matrix Test (Behavioral)
visual feedback
Patients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
干预措施: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire (Behavioral)
结局指标
主要结局
Short term rehabilitation effect on the spatial auditory performance - 4 sessions
时间窗: 4 weeks after inclusion
This effect will be defined as any change in auditory performance scores (3d-D value OR SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and short term rehabilitation (4 rehabilitation sessions)
Short term rehabilitation effect on the spatial auditory performance - 8 sessions
时间窗: 6 weeks after inclusion
This effect will be defined as any change in auditory performance scores (3d-D value OR SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and short term rehabilitation (8 rehabilitation sessions)
次要结局
- Short term feedback effect on spatial auditory performance(6 weeks after inclusion)
- Percentage of sessions performed on all the rehabilitation sessions during the protocol(6 weeks after inclusion)
- Measure of auditory performance tests own effect(2 weeks after inclusion)
- Middle term feedback effect on spatial auditory performance(10 to 12 weeks after inclusion)
- Middle term rehabilitation effect on the spatial auditory performance(10 to 12 weeks after inclusion)
- Short term feedback effect on spatial auditory performance(4 weeks after inclusion)