Auditory Diagnostics and Error-based Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Percent Speech Recognition
研究概览
简要总结
The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.
The participants will undergo 1 visit lasting approximately 2 hours at the Radboud university medical center's ENT department, where they will undergo a series of diagnostic tests. Some of the participants will also be asked to self-administer additional tests using a Windows tablet.
Based on the outcomes of speech recognition tests in quiet at the first visit, the participants will be called for follow-up interventions concerning both the fitting of their CI and personalized auditory training based on their personal error patterns. These interventions will take place over the course of approximately 5 months and will be made up of three follow-up visits and a period of self-administered training through a mobile application on a tablet.
One final follow-up visit will check whether any changes from the interventions are retained after four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult (over 18 years old at the time of inclusion )
- •Post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness)
- •Native Dutch speaker
- •Implanted, either unilaterally or bilaterally, with a Cochlear Implant manufactured by Cochlear Ltd (i.e., a Nucleus ® implant).
- •Implanted with one of the following implants: CI422, CI512, CI522, CI532, CI24M, CI24R, CI24RE.
- •Implanted for at least 12 months.
排除标准
- •Known abnormally formed cochlea
- •Known pre-implantation ossification of the cochlea
- •Severe cognitive disorders affecting their ability to understand spoken language
- •Intense facial nerve stimulation
- •Unaddressed electrode tip foldover
- •More than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response
- •Additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.
结局指标
主要结局
Change in Percent Speech Recognition
时间窗: Weeks 1, 10, 14, 18
Given a list of CNC words, this score measures the percentage of correctly identified words.
次要结局
- Change in Error Dispersion(Weeks 1, 10, 14, 18)
- Change in Distance-based Accuracy Score(Weeks 1, 10, 14, 18)