- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04041440
Speech Recognition Training in Children With Hearing Loss (ChAT)
2021년 10월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
34
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 62220
- Washington University School of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
8년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Children with moderate to severe hearing loss.
Exclusion Criteria:
- Must be native English speakers
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Auditory Training
Pre- and post assessments of auditory training intervention
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Children play auditory brain training computer games
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Words Identified Before and After Training
기간: Before and after the four week training period
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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.
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Before and after the four week training period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Processing Speed
기간: over course of 4 weeks
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How quickly, in milliseconds, a word can be discriminated from a competitor
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over course of 4 weeks
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Working Memory
기간: over course of 4 weeks
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Number of words remembered from a list of words presented sequentially
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over course of 4 weeks
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Subjective Assessment of clEAR Games on a 7-Point Scale
기간: Measured once, after the four week training period
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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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chris A Cardinal, PhD, clEAR: Customized Hearing
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 9월 1일
기본 완료 (실제)
2020년 9월 16일
연구 완료 (실제)
2020년 9월 16일
연구 등록 날짜
최초 제출
2019년 7월 26일
QC 기준을 충족하는 최초 제출
2019년 7월 30일
처음 게시됨 (실제)
2019년 8월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 11월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 10월 12일
마지막으로 확인됨
2021년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 201602007
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Only descriptive data will be shared with other researchers
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .