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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Deafness, Speech Intelligibility

Intervention / Treatment
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* Other: Cognitive fitness training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Immediate cognitive fitness training<br>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. | Other: Cognitive fitness training<br>* Computer-based training of basic cognitive functions. It has activities under two headings, General training applications 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.<br>|
| Other: Delayed cognitive fitness training<br>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. | Other: Cognitive fitness training<br>* Computer-based training of basic cognitive functions. It has activities under two headings, General training applications 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AzBio Sentence test - change in score from baseline to post-training | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in CANTABeclipse for clinical trials | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implants, speech comprehension, cognitive training, cognitive fitness, intervention, memory, attention, rehabilitation