Overview

This trial is active, not recruiting.

Conditions deafness, speech intelligibility
Treatment cognitive fitness training
Sponsor Aaron Newman
Collaborator University of Oslo
Start date January 2013
End date November 2015
Trial size 100 participants
Trial identifier NCT01732887, NCIL-CI-CF

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
cognitive fitness training
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.
(Other)
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.
cognitive fitness training
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.

Primary Outcomes

Measure
AzBio Sentence test - change in score from baseline to post-training
time frame: Baseline, Weeks 10, 20 and 30

Secondary Outcomes

Measure
Change from Baseline in CANTABeclipse for clinical trials
time frame: Baseline, Weeks 10, 20 and 30
Change from Baseline in Speech Spatial Qualities questionnaire
time frame: Baseline, Weeks 10, 20 and 30
Change from Baseline in CogniFit NeuroPsychological Assessment
time frame: Baseline, Weeks 10, 20 and 30
Adherence record
time frame: Upto 30 weeks

Eligibility Criteria

Male or female participants at least 19 years old.

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.

Additional Information

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
Principal investigator Aaron Newman, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Capital District Health Authority, Canada.