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

Primary Purpose

Deafness, Speech Intelligibility

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive fitness training
Sponsored by
Aaron Newman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness focused on measuring cochlear implants, speech comprehension, cognitive training, cognitive fitness, intervention, memory, attention, rehabilitation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NeuroCognitive Imaging Lab, Dalhousie University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate cognitive fitness training

Delayed cognitive fitness training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)
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

Full Information

First Posted
November 14, 2012
Last Updated
January 31, 2017
Sponsor
Aaron Newman
Collaborators
University of Oslo, CogniFit Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01732887
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
We were not able to recruit enough participants during the funding period.
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aaron Newman
Collaborators
University of Oslo, CogniFit Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Speech Intelligibility
Keywords
cochlear implants, speech comprehension, cognitive training, cognitive fitness, intervention, memory, attention, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate cognitive fitness training
Arm Type
Other
Arm Description
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.
Arm Title
Delayed cognitive fitness training
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive fitness training
Intervention Description
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 Outcome Measure Information:
Title
AzBio Sentence test - change in score from baseline to post-training
Description
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.
Time Frame
Baseline, Weeks 10, 20 and 30
Secondary Outcome Measure Information:
Title
Change from Baseline in CANTABeclipse for clinical trials
Description
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.
Time Frame
Baseline, Weeks 10, 20 and 30
Title
Change from Baseline in Speech Spatial Qualities questionnaire
Description
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.
Time Frame
Baseline, Weeks 10, 20 and 30
Title
Change from Baseline in CogniFit NeuroPsychological Assessment
Description
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)
Time Frame
Baseline, Weeks 10, 20 and 30
Title
Adherence record
Description
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
Time Frame
Upto 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Newman, PhD
Organizational Affiliation
Dalhousie University, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoph Gradmann
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroCognitive Imaging Lab, Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.ncilab.ca/
Description
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.
URL
http://www.uio.no/english/studies/programmes/ichealth-master/
Description
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.
URL
http://psychology.dal.ca/
Description
The clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada

Learn more about this trial

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

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