Speech Recognition Training in Children With Hearing Loss (ChAT)
Primary Purpose
Hearing Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
clEAR auditory training
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Auditory training, Children with hearing loss
Eligibility Criteria
Inclusion Criteria:
- Children with moderate to severe hearing loss.
Exclusion Criteria:
- Must be native English speakers
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Auditory Training
Arm Description
Pre- and post assessments of auditory training intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Processing Speed
How quickly, in milliseconds, a word can be discriminated from a competitor
Working Memory
Number of words remembered from a list of words presented sequentially
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.
How much did you like the home training program?
Do you think playing the games improved your speech discrimination abilities? (how well you understand speech)
Do you think playing the games improved your confidence in conversation?
Did you enjoy playing the games in your home?
How likely would you be to tell your friends who have hearing loss about this program?
Participants were asked to respond to each item using this scale:
(very little) 1 2 3 4 5 6 7 (very much)
Full Information
NCT ID
NCT04041440
First Posted
July 26, 2019
Last Updated
October 12, 2021
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04041440
Brief Title
Speech Recognition Training in Children With Hearing Loss
Acronym
ChAT
Official Title
Customized Auditory Brain Training for Children With Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Auditory training, Children with hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Within subjects A1 - A2 - B1 - B2 design
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auditory Training
Arm Type
Experimental
Arm Description
Pre- and post assessments of auditory training intervention
Intervention Type
Behavioral
Intervention Name(s)
clEAR auditory training
Intervention Description
Children play auditory brain training computer games
Primary Outcome Measure Information:
Title
Percentage of Words Identified Before and After Training
Description
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.
Time Frame
Before and after the four week training period
Secondary Outcome Measure Information:
Title
Processing Speed
Description
How quickly, in milliseconds, a word can be discriminated from a competitor
Time Frame
over course of 4 weeks
Title
Working Memory
Description
Number of words remembered from a list of words presented sequentially
Time Frame
over course of 4 weeks
Title
Subjective Assessment of clEAR Games on a 7-Point Scale
Description
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.
How much did you like the home training program?
Do you think playing the games improved your speech discrimination abilities? (how well you understand speech)
Do you think playing the games improved your confidence in conversation?
Did you enjoy playing the games in your home?
How likely would you be to tell your friends who have hearing loss about this program?
Participants were asked to respond to each item using this scale:
(very little) 1 2 3 4 5 6 7 (very much)
Time Frame
Measured once, after the four week training period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with moderate to severe hearing loss.
Exclusion Criteria:
Must be native English speakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris A Cardinal, PhD
Organizational Affiliation
clEAR: Customized Hearing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
62220
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only descriptive data will be shared with other researchers
Learn more about this trial
Speech Recognition Training in Children With Hearing Loss
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