Hearing Loss
Conditions
Keywords
Auditory training, Children with hearing loss
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.
Interventions
BEHAVIORALclEAR auditory training
Children play auditory brain training computer games
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Within subjects A1 - A2 - B1 - B2 design
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children with moderate to severe hearing loss.
Exclusion criteria
* Must be native English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Words Identified Before and After Training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Processing Speed | over course of 4 weeks | How quickly, in milliseconds, a word can be discriminated from a competitor |
| Working Memory | over course of 4 weeks | Number of words remembered from a list of words presented sequentially |
| Subjective Assessment of clEAR Games on a 7-Point Scale | 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. 1. How much did you like the home training program? 2. Do you think playing the games improved your speech discrimination abilities? (how well you understand speech) 3. Do you think playing the games improved your confidence in conversation? 4. Did you enjoy playing the games in your home? 5. 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auditory Training Pre- and post assessments of auditory training intervention
clEAR auditory training: Children play auditory brain training computer gamesFocus | 22 |
| Focus Group Two focus groups
Focus groups to collect feedback on current version of games | 12 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Auditory Training | Total | Focus Group |
|---|---|---|---|
| Age, Continuous | 10.6 years STANDARD_DEVIATION 1.3 | 9.45 years STANDARD_DEVIATION 2.04 | 7.28 years STANDARD_DEVIATION 1.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 27 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 17 Participants | 5 Participants |
| Region of Enrollment United States | 22 participants | 34 participants | 12 participants |
| Sex: Female, Male Female | 14 Participants | 24 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 22 |
| other Total, other adverse events | 0 / 12 | 0 / 22 |
| serious Total, serious adverse events | 0 / 12 | 0 / 22 |
Outcome results
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.
Time frame: Before and after the four week training period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auditory Training Group | Percentage of Words Identified Before and After Training | Pre-Training Scores | 49.7 percentage of words presented | Standard Deviation 13.2 |
| Auditory Training Group | Percentage of Words Identified Before and After Training | Post-Training Scores | 55.7 percentage of words presented | Standard Deviation 17.6 |
Secondary
Processing Speed
How quickly, in milliseconds, a word can be discriminated from a competitor
Time frame: over course of 4 weeks
Population: 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.
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. 1. How much did you like the home training program? 2. Do you think playing the games improved your speech discrimination abilities? (how well you understand speech) 3. Do you think playing the games improved your confidence in conversation? 4. Did you enjoy playing the games in your home? 5. 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auditory Training Group | Subjective Assessment of clEAR Games on a 7-Point Scale | 5.25 Units on a 7-point scale | Standard Deviation 1.41 |
Secondary
Working Memory
Number of words remembered from a list of words presented sequentially
Time frame: over course of 4 weeks
Population: 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.