Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome is the percentage of correct speech recognition after training between the two training programs
研究概览
简要总结
In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Unilaterally postlingually-deafened adult cochlear implanted candidates (IC-Uni)
- •Person with almost normal or moderate contralateral hearing ( under 60dB)
- •Cochlear implanted person whose activation has not yet been performed
- •Cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant
- •Affiliated to social security
排除标准
- •- Subjects under juridical protections or tutelage measure
- •Subjects with associated neurological or neurodegenerative conditions
- •Significant anatomical changes on CT scan of the temporal bone that may interfere with the insertion of the cochlear implant
研究组 & 干预措施
Control
Training in bilaterally postlingually-deafened adult cochlear implanted candidates
干预措施: Control (Procedure)
Training A
Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates
干预措施: Program A (Procedure)
Training B
Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates
干预措施: Program B (Procedure)
结局指标
主要结局
The primary outcome is the percentage of correct speech recognition after training between the two training programs
时间窗: Month 12
次要结局
未报告次要终点