Speech Recognition Training in Children With Hearing Loss (ChAT)
2021年10月12日 更新者:Washington University School of Medicine
Customized Auditory Brain Training for Children With Hearing Loss
clEAR's auditory brain training has been shown to be effective in improving childrens' abilities to recognize the speech of generic talkers in a laboratory setting.
In the proposed research, the researchers will build upon these results and assess the extent to which auditory brain training delivered via the web enhances children's abilities to recognize the speech of a potential classroom teacher and diminishes their communication challenges that are associated with significant hearing loss.
First, investigators will conduct focus groups with children who have undergone training with the research version of clEAR's pediatric games, then they will recode the games from LabView to Java Script, making changes in the games in response to the focus group comments, and finally, they will collect data from 20 children to assess whether web-based auditory brain training improves their abilities to recognize the speech of their (hypothetical) upcoming school year's classroom teacher.
研究概览
详细说明
Imagine that someday, children with hearing loss can prepare for an upcoming school year by playing computer games with their new teacher's voice throughout the summer.
Then, on the first day of class, children would have that "Oprah Winfrey effect", the sense that they know the teacher.
Children would be able to recognize their teacher's voice much better than they would have otherwise, and importantly, they would experience less anxiety because of the talker familiarity effect.
clEAR is making that "someday" a reality today.
clEAR has created a new web-based clinical tool for audiologists and teachers to provide customized auditory brain training to their patients (www.clearforears.com).
Auditory brain training includes traditional analytic and synthetic training as well as training to develop those auditory cognitive skills that are necessary to decode spoken language regardless of the content (i.e., auditory working memory, auditory attention, and auditory processing speed).
The centerpiece of the clEAR website is a set of auditory brain training games that patients play, with oversight and coaching from their hearing healthcare provider or from one of clEAR's inhouse audiologists.
Currently, clEAR caters to adult patients, and the games require some reading ability and a vocabulary that includes the most common words of the English language (N=800 words).
clEAR has been enrolling paying adult subscribers since May of 2017.
In the laboratory, a research version of pediatric games is being tested.
The pediatric games are "childfriendly" and require only a limited vocabulary and no reading skills.
In this Phase 1, the investigators will first conduct focus groups with 10 children who have undergone training with the research version of clEAR's pediatric games, then they will recode the games from LabView to Java Script, making changes in the games in response to the focus group comments, and finally, they will collect data from 20 children to assess whether web-based auditory brain training improves their abilities to recognize the speech of their (hypothetical) upcoming school year's classroom teacher.
The experimental design will be a within-subjects A1-A2-B1-B2 design, where children will serve as their own controls.
Participants will be tested two times before training with a one-week interval separating the test sessions (A1 and A2), to establish a baseline performance, and then immediately after training (B1) to establish immediate gains and three weeks later to assess whether gains begin to decline following training (B2).
All testing and training will occur during the summer so the experimental results will not be confounded by benefits possibly accrued through school-related activities.
Children will complete a total of 16 hours of training and will follow the same schedule (i.e., play the games in a prescribed order and for a set amount of time each).
Outcome measures will come from a comprehensive speech perception test battery, questionnaires, and from data collected during training and stored on the children's training tablets.
In Phase II, the pediatric games will be transferred to the clEAR website and develop their commercial potential.
研究类型
介入性
注册 (实际的)
34
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Missouri
-
Saint Louis、Missouri、美国、62220
- Washington University School of Medicine
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 12年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Children with moderate to severe hearing loss.
Exclusion Criteria:
- Must be native English speakers
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Auditory Training
Pre- and post assessments of auditory training intervention
|
Children play auditory brain training computer games
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Words Identified Before and After Training
大体时间:Before and after the four week training period
|
The measure is percent of 50 common words correctly identified.
Words were presented through the application and responses were recorded and scored by the audiologist administering the test.
|
Before and after the four week training period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Processing Speed
大体时间:over course of 4 weeks
|
How quickly, in milliseconds, a word can be discriminated from a competitor
|
over course of 4 weeks
|
|
Working Memory
大体时间:over course of 4 weeks
|
Number of words remembered from a list of words presented sequentially
|
over course of 4 weeks
|
|
Subjective Assessment of clEAR Games on a 7-Point Scale
大体时间:Measured once, after the four week training period
|
clEAR Questionnaire is given to provide researchers feedback and suggestions about the clEAR games from the child's perspective. The questionnaire used 7-point Likert scales, yes-no questions, open ended questions. Average scores across all of the Likert scale questions are reported here because they are quantifiable. Here are the questions analyzed.
Participants were asked to respond to each item using this scale: (very little) 1 2 3 4 5 6 7 (very much) |
Measured once, after the four week training period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Chris A Cardinal, PhD、clEAR: Customized Hearing
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月1日
初级完成 (实际的)
2020年9月16日
研究完成 (实际的)
2020年9月16日
研究注册日期
首次提交
2019年7月26日
首先提交符合 QC 标准的
2019年7月30日
首次发布 (实际的)
2019年8月1日
研究记录更新
最后更新发布 (实际的)
2021年11月10日
上次提交的符合 QC 标准的更新
2021年10月12日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.