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Speech Recognition Training in Children With Hearing Loss (ChAT)

12 octobre 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

34

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Missouri
      • Saint Louis, Missouri, États-Unis, 62220
        • Washington University School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

8 ans à 12 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Children with moderate to severe hearing loss.

Exclusion Criteria:

  • Must be native English speakers

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Auditory Training
Pre- and post assessments of auditory training intervention
Children play auditory brain training computer games

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Words Identified Before and After Training
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Processing Speed
Délai: over course of 4 weeks
How quickly, in milliseconds, a word can be discriminated from a competitor
over course of 4 weeks
Working Memory
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Chris A Cardinal, PhD, clEAR: Customized Hearing

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2019

Achèvement primaire (Réel)

16 septembre 2020

Achèvement de l'étude (Réel)

16 septembre 2020

Dates d'inscription aux études

Première soumission

26 juillet 2019

Première soumission répondant aux critères de contrôle qualité

30 juillet 2019

Première publication (Réel)

1 août 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 octobre 2021

Dernière vérification

1 octobre 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Only descriptive data will be shared with other researchers

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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