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

NCT ID: NCT01732887

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Deafness; Speech Intelligibility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Cognitive fitness training

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Cognitive fitness training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

CogniFit Limited

UNKNOWN

Sponsor Role: collaborator

Aaron Newman

OTHER

Sponsor Role: lead

Responsible Party

Aaron Newman

Affiliated Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aaron Newman, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University, Canada

Christoph Gradmann

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

NeuroCognitive Imaging Lab, Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

Related Links

http://www.ncilab.ca/

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.

http://www.uio.no/english/studies/programmes/ichealth-master/

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.

http://psychology.dal.ca/

The clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada

Other Identifiers

NCIL-CI-CF

Identifier Type: -

Identifier Source: org_study_id