Clinical trial NCT01732887: Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deafness
Speech Intelligibility
Keywords: cochlear implants
speech comprehension
cognitive training
cognitive fitness
intervention
memory
attention
rehabilitation
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: CogniFit Limited
First posted: 2012-11-26
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: AzBio Sentence test - change in score from baseline to post-training
timeFrame: Baseline, Weeks 10, 20 and 30
Secondary outcomes:
measure: Change from Baseline in CANTABeclipse for clinical trials
timeFrame: Baseline, Weeks 10, 20 and 30
measure: Change from Baseline in Speech Spatial Qualities questionnaire
timeFrame: Baseline, Weeks 10, 20 and 30
measure: Change from Baseline in CogniFit NeuroPsychological Assessment
timeFrame: Baseline, Weeks 10, 20 and 30
measure: Adherence record
timeFrame: Upto 30 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: NeuroCognitive Imaging Lab, Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University, Canada
name: Aaron Newman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Christoph Gradmann
role: PRINCIPAL_INVESTIGATOR
References: