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

Deafness Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01732887
• Other study ID #: NCIL-CI-CF
• Status: Terminated
• Phase: N/A
• First received: November 14, 2012
• Last updated: January 31, 2017
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Speech Intelligibility

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	NeuroCognitive Imaging Lab, Dalhousie University	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
Aaron Newman	CogniFit Limited, University of Oslo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External 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 clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada
•   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.