<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732887</url>
  </required_header>
  <id_info>
    <org_study_id>NCIL-CI-CF</org_study_id>
    <nct_id>NCT01732887</nct_id>
  </id_info>
  <brief_title>Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aaron Newman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CogniFit Limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we are testing computer-based brain fitness exercises. The games are designed&#xD;
      to improve people's cognitive abilities brain functions, like memory, concentration, and&#xD;
      ability to do two things at once. We are testing whether this cognitive training brain&#xD;
      exercises will improve understanding of spoken sentences speech comprehension in people who&#xD;
      use cochlear implant and/or hearing aids. We predict that cognitive training will improve&#xD;
      speech comprehension in cochlear implant and/or hearing aid users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aural rehabilitation is a life long process in spite of advanced innovative implant&#xD;
      technology. Existing standard therapy is inadequate for some people, because even after years&#xD;
      of surgery many implant users does not obtain significant benefits, like improved&#xD;
      understanding of spoken sentences. In many cases it seems that the speech comprehension&#xD;
      deficits are linked to particular cognitive functions in cochlear implant users, including&#xD;
      memory and attention. In this study we will test whether a computer-based set of &quot;cognitive&#xD;
      fitness&quot; or &quot;brain training&quot; games designed to improve memory and attention will help&#xD;
      cochlear implant and hearing aid users to understand speech better.&#xD;
&#xD;
      Cochlear implant and hearing aid users will complete 10 weeks of computer-based cognitive&#xD;
      training on their home computers. Half of participants will do this training immediately&#xD;
      after being enrolled in the study; the other half will receive the training beginning 10&#xD;
      weeks after they are enrolled. Speech comprehension and cognitive abilities will be assessed&#xD;
      at baseline, 10, 20 and 30 weeks in all participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    We were not able to recruit enough participants during the funding period.&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AzBio Sentence test - change in score from baseline to post-training</measure>
    <time_frame>Baseline, Weeks 10, 20 and 30</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in CANTABeclipse for clinical trials</measure>
    <time_frame>Baseline, Weeks 10, 20 and 30</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Speech Spatial Qualities questionnaire</measure>
    <time_frame>Baseline, Weeks 10, 20 and 30</time_frame>
    <description>The Spatial Speech Qualities of Hearing scale questionnaire (SSQ; Gatehouse &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in CogniFit NeuroPsychological Assessment</measure>
    <time_frame>Baseline, Weeks 10, 20 and 30</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence record</measure>
    <time_frame>Upto 30 weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Deafness</condition>
  <condition>Speech Intelligibility</condition>
  <arm_group>
    <arm_group_label>Immediate cognitive fitness training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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 &quot;no intervention&quot; period where they receive only standard of care treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed cognitive fitness training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After the initial baseline evaluation, the delayed cognitive fitness training group participants will receive only standard of care for 10 weeks (&quot;no intervention&quot; 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive fitness training</intervention_name>
    <description>Computer-based training of basic cognitive functions. It has activities under two headings,&#xD;
General training applications&#xD;
Memory training applications&#xD;
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.</description>
    <arm_group_label>Delayed cognitive fitness training</arm_group_label>
    <arm_group_label>Immediate cognitive fitness training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult cochlear implant users, and/or people with moderate/severe hearing loss using&#xD;
             bilateral hearing aids, aged 19 or above&#xD;
&#xD;
          -  Access to an internet-connect device that supports flash, and basic computer skills&#xD;
&#xD;
          -  Medically stable patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with epilepsy, severe visual and cognitive difficulties, chronic fatigue&#xD;
             syndrome, and serious co-morbid conditions which could be exacerbated by the computer&#xD;
             training games will be excluded for safety reasons.&#xD;
&#xD;
          -  Patients who are unlikely to adhere to the intervention due to dementia, Parkinson's&#xD;
             disease, Parkinson-plus syndrome, movement disorders or disability that would impair&#xD;
             the person's ability to perform the training (e.g., problems with attention,&#xD;
             alertness, or learning disorders)&#xD;
&#xD;
          -  Participants who cannot speak English (since study materials are only in English), or&#xD;
             unable to give consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Newman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University, Canada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christoph Gradmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NeuroCognitive Imaging Lab, Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 4R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.ncilab.ca/</url>
    <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.</description>
  </link>
  <link>
    <url>http://www.uio.no/english/studies/programmes/ichealth-master/</url>
    <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.</description>
  </link>
  <link>
    <url>http://psychology.dal.ca/</url>
    <description>The clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Aaron Newman</investigator_full_name>
    <investigator_title>Affiliated Scientist</investigator_title>
  </responsible_party>
  <keyword>cochlear implants</keyword>
  <keyword>speech comprehension</keyword>
  <keyword>cognitive training</keyword>
  <keyword>cognitive fitness</keyword>
  <keyword>intervention</keyword>
  <keyword>memory</keyword>
  <keyword>attention</keyword>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732887
org study id: NCIL-CI-CF
nct id: NCT01732887
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AzBio Sentence test - change in score from baseline to post-training
time frame: Baseline, Weeks 10, 20 and 30
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.
measure: Change from Baseline in CANTABeclipse for clinical trials
time frame: Baseline, Weeks 10, 20 and 30
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.
measure: Change from Baseline in Speech Spatial Qualities questionnaire
time frame: Baseline, Weeks 10, 20 and 30
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.
measure: Change from Baseline in CogniFit NeuroPsychological Assessment
time frame: Baseline, Weeks 10, 20 and 30
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)
measure: Adherence record
time frame: Upto 30 weeks
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
arm group label: Immediate cognitive fitness training
arm group type: Other
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 group label: Delayed cognitive fitness training
arm group type: Other
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: Cognitive fitness training
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.
arm group label: Delayed cognitive fitness training
arm group label: Immediate cognitive fitness training
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Aaron Newman, PhD
role: Principal Investigator
affiliation: Dalhousie University, Canada
last name: Christoph Gradmann
role: Principal Investigator
affiliation: University of Oslo
facility: 
country: Canada
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
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Aaron Newman
investigator title: Affiliated Scientist
mesh term: Deafness