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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory Training | Experimental | Pre- and post assessments of auditory training intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clEAR auditory training | Behavioral | Children play auditory brain training computer games |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Words Identified Before and After Training | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Processing Speed | How quickly, in milliseconds, a word can be discriminated from a competitor | over course of 4 weeks |
| Working Memory | Number of words remembered from a list of words presented sequentially |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris A Cardinal, PhD | clEAR: Customized Hearing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 62220 | United States |
Only descriptive data will be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Focus Groups | Two groups of children participated in focus groups (N=7 and N=5). Results of subjective questions and focused conversations from the focus groups were used to update and modify the clEAR games to make them more fun and engaging. |
| FG001 | Auditory Training Group | One group of children participated in auditory training (N=20 completed the protocol, 22 were consented). Results of objective pre- and post-training assessments from the training group were compared to evaluate the effectiveness of the games. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Auditory Training | Pre- and post assessments of auditory training intervention clEAR auditory training: Children play auditory brain training computer gamesFocus |
| BG001 | Focus Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Words Identified Before and After Training | 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. | Data are for children with hearing loss who participated in the auditory training part of the study. One participant in the auditory training group was unable to complete the assessments before and after the training because their speech perception ability was below the level of the assessment material. They were allowed to continue the training part of the study to see if they could still be helped by the training. Outcome measures were not collected from the Focus group. | Posted | Mean | Standard Deviation | percentage of words presented | Before and after the four week training period |
|
Three Months
No adverse events were anticipated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Focus Groups | Two groups of children participated in focus groups (N=7 and N=5). Results of subjective questions and focused conversations from the focus groups were used to update and modify the clEAR games to make them more fun and engaging. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Customized Learning Exercises for Aural Rehabilitation | 314 399-9943 | chris@amptify.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2020 | Feb 15, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Information Sheet for Participation in AT | May 13, 2020 | Feb 15, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent for Focus group | Dec 3, 2019 | Feb 15, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Within subjects A1 - A2 - B1 - B2 design
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| over course of 4 weeks |
| Subjective Assessment of clEAR Games on a 7-Point Scale | 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 |
Two focus groups
Focus groups to collect feedback on current version of games
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Processing Speed | How quickly, in milliseconds, a word can be discriminated from a competitor | Data were not collected as the protocol was revised to include only testing that could be conducted remotely. This type of cognitive task requires monitored testing procedures. | Posted | over course of 4 weeks |
|
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| Secondary | Working Memory | Number of words remembered from a list of words presented sequentially | Data were not collected as the protocol was revised to include only testing that could be conducted remotely. This type of cognitive task requires monitored testing procedures. | Posted | over course of 4 weeks |
|
|
| Secondary | Subjective Assessment of clEAR Games on a 7-Point Scale | 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) | Data are for children with hearing loss who participated in the auditory training part of the study. Outcome measures were not collected from the Focus Group. | Posted | Mean | Standard Deviation | Units on a 7-point scale | Measured once, after the four week training period |
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Auditory Training Group | One group of children participated in auditory training (N=20 completed the protocol, 22 were consented). Results of objective pre- and post-training assessments from the training group were compared to evaluate the effectiveness of the games. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |