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Speech Recognition Training in Children With Hearing Loss (ChAT)

12 oktober 2021 uppdaterad av: Washington University School of Medicine

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

34

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 62220
        • Washington University School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

8 år till 12 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Children with moderate to severe hearing loss.

Exclusion Criteria:

  • Must be native English speakers

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Auditory Training
Pre- and post assessments of auditory training intervention
Children play auditory brain training computer games

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Words Identified Before and After Training
Tidsram: 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.
Before and after the four week training period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Processing Speed
Tidsram: over course of 4 weeks
How quickly, in milliseconds, a word can be discriminated from a competitor
over course of 4 weeks
Working Memory
Tidsram: over course of 4 weeks
Number of words remembered from a list of words presented sequentially
over course of 4 weeks
Subjective Assessment of clEAR Games on a 7-Point Scale
Tidsram: 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)

Measured once, after the four week training period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Chris A Cardinal, PhD, clEAR: Customized Hearing

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2019

Primärt slutförande (Faktisk)

16 september 2020

Avslutad studie (Faktisk)

16 september 2020

Studieregistreringsdatum

Först inskickad

26 juli 2019

Först inskickad som uppfyllde QC-kriterierna

30 juli 2019

Första postat (Faktisk)

1 augusti 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Only descriptive data will be shared with other researchers

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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