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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT04041440
Study groupRoleWhat they receive
Auditory TrainingExperimentalPre- 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.

  1. 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)
  1. Processing Speed

    How quickly, in milliseconds, a word can be discriminated from a competitor

    Measured: over course of 4 weeks

  2. Working Memory

    Number of words remembered from a list of words presented sequentially

    Measured: over course of 4 weeks

  3. 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)

    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.

  1. First posted1 Aug 2019
  2. Study start1 Sep 2019
  3. Primary completion16 Sep 2020
  4. Study completion16 Sep 2020

Resources

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)
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
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only descriptive data will be shared with other researchers

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.

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