Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users
31. Januar 2017 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
12
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 4R2
- NeuroCognitive Imaging Lab, Dalhousie University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
19 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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,
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. |
|
Sonstiges: 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,
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
AzBio Sentence test - change in score from baseline to post-training
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in CANTABeclipse for clinical trials
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Aaron Newman, PhD, Dalhousie University, Canada
- Hauptermittler: Christoph Gradmann, University of Oslo
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
- NeuroCognitive Imaging Lab (NCIL) is a service of Department of Psychology at Dalhousie University, Canada. Participants visit the NCIL to complete a cognitive and hearing assessment. However, they perform the training tasks from their own homes.
- The Department of Community Medicine is primary affiliation of the Sub-Investigator, Dr. Amit Bansal. He is pursuing M.Phil International Community Health at the University of Oslo, Norway under supervision of Drs. Gradmann, Lian and Newman.
- The clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2013
Primärer Abschluss (Tatsächlich)
1. Januar 2016
Studienabschluss (Tatsächlich)
1. Januar 2016
Studienanmeldedaten
Zuerst eingereicht
14. November 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. November 2012
Zuerst gepostet (Schätzen)
26. November 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
1. Februar 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. Januar 2017
Zuletzt verifiziert
1. Januar 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCIL-CI-CF
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .