Early Cochlear Implant Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in percentage of correct responses during speech perception tests
研究概览
简要总结
This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postlingually deaf cochlear implant users
- •severe or profound hearing loss
- •who do not have other diagnoses communicative or cognitive disorders.
- •Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
- •Control population: subjects who have used the same stimulation strategy since initial stimulation, who note no continuing improvements or changes with their devices with respect to speech comprehension.
排除标准
- •Diagnosed cognitive or communicative disorders (other than deafness)
- •Below 18 years of age
- •Above the age of 85 years old.
结局指标
主要结局
Change in percentage of correct responses during speech perception tests
时间窗: Baseline, 1 year
Speech perception tests involves presentation of a speech stimulus (may be a word, sentence, nonsense words, or other speech sounds) and subjects will have to indicate what they heard. The total score is the percentage of speech stimulus correctly understood, ranging from 0-100%.
次要结局
未报告次要终点