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

31 gennaio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Altro: Cognitive fitness training

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.
Altro: 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.
Altro: Cognitive fitness training

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
AzBio Sentence test - change in score from baseline to post-training
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in CANTABeclipse for clinical trials
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Aaron Newman

Collaboratori

University of Oslo
CogniFit Limited

Investigatori

  • Investigatore principale: Aaron Newman, PhD, Dalhousie University, Canada
  • Investigatore principale: Christoph Gradmann, University of Oslo

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2013

Completamento primario (Effettivo)

1 gennaio 2016

Completamento dello studio (Effettivo)

1 gennaio 2016

Date di iscrizione allo studio

Primo inviato

14 novembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

20 novembre 2012

Primo Inserito (Stima)

26 novembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 febbraio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 gennaio 2017

Ultimo verificato

1 gennaio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCIL-CI-CF

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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