Evaluation of Performance and Usability of N6 in the Paediatric Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Group usability performance data for N6 versus N5
研究概览
简要总结
The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.
详细描述
This study will evaluate the user benefits of the N6 system in the paediatric population currently equipped with N5. The performance and usability of both systems will be evaluated and compared. The performance of the N6 is expected to be at least equivalent to the N5.
Outcome measures:
- City University of New York (CUNY) Sentence Test in quiet and noise
- Consonant-Nucleus-Consonant (CNC) words in quiet
- in-house designed Usability questionnaires of the N6 system (information to be used internally)
- PEACH, TEACH and SELF questionnaires - developed by Ching & Hill (2007). PEACH - The Parents' Evaluation of Aural/oral performance of Children TEACH - The Teachers' Evaluation of Aural/oral performance of Children for teachers SELF - The Child's Self evaluation of aural/oral performance.
Speech perception tests will be administered at baseline, then again three times, two weeks apart with the N6 processor - i.e. week 0, week 2, week 4 & week 6. Total time: 2 months.
Questionnaires will also be given at the same time points, to get baseline information, as well as N6 information
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5-14 years, currently using N5
- •Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR).
- •Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor
- •Excellent verbal reporters
- •Excellent record of attending clinical appointments.
- •Attend a regular school,
- •English 1st language.
- •Excellent record of compliance with habilitation tasks.
排除标准
- •Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements
- •Inability to attend study appointments.
结局指标
主要结局
Group usability performance data for N6 versus N5
时间窗: Nov 2012-June 2013
The investigational sound processor, remote assistant and fitting software will be compared to the existing implant system on measures of speech perception and usability in a take-home study.
次要结局
- speech recognition scores in quiet and noise between the two processors(Nov 2012-June 2013)
- Useability questionnaire on the different sound processing features(Nov 2012-June 2013)
- Subjective feedback on performance as well as patient preference between the 2 processors(Nov 2012-June 2013)
- Evaluate the usability of the two systems in a group of children, their carers and their teachers(Nov 2012-June 2013)
- Clinical recommendations for fitting paediatric recipients with the new processor(Nov 2012-June 2013)