Hearing LossPhase 1ChATNCT04041440
Speech Recognition Training in Children With Hearing Loss
A Phase 1 study testing clEAR auditory training in people with Hearing Loss, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- clEAR auditory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 16 Sep 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with moderate to severe hearing loss.
Who cannot join
- Must be native English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 62220
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- clEAR auditory training
- Keywords
- Auditory training, Children with hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clEAR auditory trainingBehavioural
Children play auditory brain training computer games
| Study group | Role | What they receive |
|---|---|---|
| Auditory Training | Experimental | Pre- and post assessments of auditory training intervention Receives: Behavioral: clEAR auditory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the four week training period
Secondary outcomes (3)
Processing Speed
How quickly, in milliseconds, a word can be discriminated from a competitor
Measured: over course of 4 weeks
Working Memory
Number of words remembered from a list of words presented sequentially
Measured: 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.
- 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)
Measured: Measured once, after the four week training period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Sep 2019
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subjects A1 - A2 - B1 - B2 design
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris A Cardinal, PhD, Principal investigator, clEAR: Customized Hearing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041440
- Sponsor's protocol ID
- 201602007
- Acronym
- ChAT
- Status last verified
- Oct 2021
- First submitted
- 26 Jul 2019
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only descriptive data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Auditory Brain Training for Children With Hearing Loss
- ClinicalTrials.gov ID
- NCT04041440
- Acronym / sponsor ID
- ChAT / 201602007
- Conditions
- Hearing Loss
- Keywords
- Auditory training, Children with hearing loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subjects A1 - A2 - B1 - B2 design
| Arm | Type | Receives |
|---|---|---|
| Auditory Training | Experimental | Behavioral: clEAR auditory trainingPre- and post assessments of auditory training intervention |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with moderate to severe hearing loss.
Key exclusion criteria (1 listed)
- Must be native English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clEAR auditory trainingChildren play auditory brain training computer games | Behavioural | Auditory Training |
Primary outcome
Percentage of Words Identified Before and After Training
Time frame: 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.
3 secondary outcomes
Processing Speed
Time frame: over course of 4 weeks
Working Memory
Time frame: over course of 4 weeks
Subjective Assessment of clEAR Games on a 7-Point Scale
Time frame: Measured once, after the four week training period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only descriptive data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris A Cardinal, PhD principal investigator
clEAR: Customized Hearing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clEAR auditory training in people with Hearing Loss, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Words Identified Before and After Training (time frame: Before and after the four week training period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.