DeafnessNCT01732887
Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users
A study testing Cognitive fitness training in people with Deafness and Speech Intelligibility, run by Aaron Newman at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Deafness, Speech Intelligibility
- What is being tested?
- Cognitive fitness training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
NeuroCognitive Imaging Lab, Dalhousie University
Halifax, Nova Scotia, B3H 4R2
About this study
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
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.
Read the 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
- Being tested
- Cognitive fitness training
- Keywords
- cochlear implants, speech comprehension, cognitive training, cognitive fitness, intervention, memory, attention, rehabilitation
- Medical subject headings
- Deafness, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive fitness trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate cognitive fitness training | 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. Receives: Other: Cognitive fitness training |
| Delayed cognitive fitness training | 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. Receives: Other: Cognitive fitness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Weeks 10, 20 and 30
Secondary outcomes (4)
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.
Measured: Baseline, Weeks 10, 20 and 30
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.
Measured: Baseline, Weeks 10, 20 and 30
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)
Measured: Baseline, Weeks 10, 20 and 30
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
Measured: Upto 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: We were not able to recruit enough participants during the funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Newman
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Cognifit
- Responsible party
- Sponsor-investigator, Aaron Newman, Nova Scotia Health Authority
- Investigators
- Aaron Newman, PhD, Principal investigator, Dalhousie University, CanadaChristoph Gradmann, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732887
- Sponsor's protocol ID
- NCIL-CI-CF
- Status last verified
- Jan 2017
- First submitted
- 14 Nov 2012
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01732887
- Acronym / sponsor ID
- NCIL-CI-CF
- Conditions
- Deafness, Speech Intelligibility
- Keywords
- cochlear implants, speech comprehension, cognitive training, cognitive fitness, intervention, memory, attention, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were not able to recruit enough participants during the funding period.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aaron NewmanUniversity, hospital or other
- Collaborators
- University of Oslo, Cognifit
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate cognitive fitness training | Other | Other: Cognitive fitness trainingAfter 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. |
| Delayed cognitive fitness training | Other | Other: Cognitive fitness trainingAfter 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive fitness trainingComputer-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. | Other | Delayed cognitive fitness training, Immediate cognitive fitness training |
Primary outcome
AzBio Sentence test - change in score from baseline to post-training
Time frame: Baseline, Weeks 10, 20 and 30
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.
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: We were not able to recruit enough participants during the funding period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- The clinical trial is conducted at the Department of Psychology, Dalhousie University, CanadaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Newman, PhD principal investigator
Dalhousie University, Canada
Christoph Gradmann principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive fitness training in people with Deafness and Speech Intelligibility, run by Aaron Newman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We were not able to recruit enough participants during the funding period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AzBio Sentence test - change in score from baseline to post-training (time frame: Baseline, Weeks 10, 20 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.