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Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users

31 janvier 2017 mis à jour par: Aaron Newman

Evaluating Short-term Effects of Home-based Computerized Multi-domain Cognitive Training in Adult Cochlear Implant and/or Hearing Aid Users: A Prospective Randomized Intervention Study

In this study we are testing computer-based brain fitness exercises. The games are designed to improve people's cognitive abilities brain functions, like memory, concentration, and ability to do two things at once. We are testing whether this cognitive training brain exercises will improve understanding of spoken sentences speech comprehension in people who use cochlear implant and/or hearing aids. We predict that cognitive training will improve speech comprehension in cochlear implant and/or hearing aid users.

Aperçu de l'étude

Statut

Résilié

Intervention / Traitement

Description détaillée

Aural rehabilitation is a life long process in spite of advanced innovative implant technology. Existing standard therapy is inadequate for some people, because even after years of surgery many implant users does not obtain significant benefits, like improved understanding of spoken sentences. In many cases it seems that the speech comprehension deficits are linked to particular cognitive functions in cochlear implant users, including memory and attention. In this study we will test whether a computer-based set of "cognitive fitness" or "brain training" games designed to improve memory and attention will help cochlear implant and hearing aid users to understand speech better.

Cochlear implant and hearing aid users will complete 10 weeks of computer-based cognitive training on their home computers. Half of participants will do this training immediately after being enrolled in the study; the other half will receive the training beginning 10 weeks after they are enrolled. Speech comprehension and cognitive abilities will be assessed at baseline, 10, 20 and 30 weeks in all participants.

Type d'étude

Interventionnel

Inscription (Réel)

12

Phase

  • N'est pas applicable

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

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4R2
        • NeuroCognitive Imaging Lab, Dalhousie University

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

19 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Adult cochlear implant users, and/or people with moderate/severe hearing loss using bilateral hearing aids, aged 19 or above
  • Access to an internet-connect device that supports flash, and basic computer skills
  • Medically stable patients

Exclusion Criteria:

  • Patients with epilepsy, severe visual and cognitive difficulties, chronic fatigue syndrome, and serious co-morbid conditions which could be exacerbated by the computer training games will be excluded for safety reasons.
  • Patients who are unlikely to adhere to the intervention due to dementia, Parkinson's disease, Parkinson-plus syndrome, movement disorders or disability that would impair the person's ability to perform the training (e.g., problems with attention, alertness, or learning disorders)
  • Participants who cannot speak English (since study materials are only in English), or unable to give consent.

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: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Immediate cognitive fitness training
After the initial baseline evaluation, the immediate treatment group participants will receive individualized multi-domain cognitive training and standard of care. Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval. After 10 weeks of cognitive fitness training, participants in this group will switch to a 20 week "no intervention" period where they receive only standard of care treatment.

Computer-based training of basic cognitive functions. It has activities under two headings,

  1. General training applications
  2. Memory training applications

Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval.

Autre: Delayed cognitive fitness training
After the initial baseline evaluation, the delayed cognitive fitness training group participants will receive only standard of care for 10 weeks ("no intervention" period). Starting in week 11, participants in this arm will receive individualized multi-domain cognitive training and standard of care. Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval. After 10 weeks of cognitive fitness training, participants will go for another 10 weeks with only standard of care treatment.

Computer-based training of basic cognitive functions. It has activities under two headings,

  1. General training applications
  2. Memory training applications

Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
AzBio Sentence test - change in score from baseline to post-training
Délai: Baseline, Weeks 10, 20 and 30
Sentences are played along with masking noise (multi-talker babble). Participants must repeat each sentence as they heard it. Accuracy in repeating the sentences is the outcome measure.
Baseline, Weeks 10, 20 and 30

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in CANTABeclipse for clinical trials
Délai: Baseline, Weeks 10, 20 and 30
It is a method of assessing the brain-functions of a person using computerized non-linguistic tests by touch screen technology making it rapid and safe. It has been widely used globally to assess brain-functions in more than 100 disorders. More than 700 articles have been published using CANTABeclipse by over 500 academic institutions or industry researchers in 60 different countries. Tasks are performed by touch screen technology. It assesses brain-functions such as planning, problem solving, working memory etc.
Baseline, Weeks 10, 20 and 30
Change from Baseline in Speech Spatial Qualities questionnaire
Délai: Baseline, Weeks 10, 20 and 30
The Spatial Speech Qualities of Hearing scale questionnaire (SSQ; Gatehouse & Noble, 2004) is used to assess the self reported hearing disabilities across several domains such as hearing speech in challenging contexts and to the directional, distance and movement components of spatial hearing.
Baseline, Weeks 10, 20 and 30
Change from Baseline in CogniFit NeuroPsychological Assessment
Délai: Baseline, Weeks 10, 20 and 30
The CogniFit Neuropsychological assessment is a multi domain cognitive task. It measures 18 cognitive abilities such as visuospatial working memory, visuospatial learning, focused attention, updating, monitoring etc. (Haimov et al., 2008; Peretz et al., 2011b; Shatil et al., 2010; Verghese et al., 2010)
Baseline, Weeks 10, 20 and 30
Adherence record
Délai: Upto 30 weeks
Access usage data from CogniFit website will be recorded. Recording includes time spent on each session (start and end time), number of games played during each session
Upto 30 weeks

Collaborateurs et enquêteurs

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

Parrainer

Les enquêteurs

  • Chercheur principal: Aaron Newman, PhD, Dalhousie University, Canada
  • Chercheur principal: Christoph Gradmann, University of Oslo

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

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

1 janvier 2013

Achèvement primaire (Réel)

1 janvier 2016

Achèvement de l'étude (Réel)

1 janvier 2016

Dates d'inscription aux études

Première soumission

14 novembre 2012

Première soumission répondant aux critères de contrôle qualité

20 novembre 2012

Première publication (Estimation)

26 novembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 février 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 janvier 2017

Dernière vérification

1 janvier 2017

Plus d'information

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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