xml: <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/NCT05990335</url>
    </required_header>
    <id_info>
      <org_study_id>NX-21270</org_study_id>
      <nct_id>NCT05990335</nct_id>
    </id_info>
    <brief_title>Boost Study 21270 (Cognition)</brief_title>
    <official_title>Mobile Software Application Intervention Including Cognitive Tasks</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NXTech</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kansas State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>NXTech</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is designed to to test the technical feasibility of encouraging interaction with a&#xD;
        mobile smartphone software package (mHealth app) for training aspects of executive function&#xD;
        and cognition.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this human subjects study is to test the technical feasibility of interaction&#xD;
        with a mobile smartphone software package (mHealth app) for training in aspects of executive&#xD;
        function and cognition. The study participants are healthy subjects recruited online, with&#xD;
        consent secured at the time of screening, and with enrollees assigned to High or Low groups&#xD;
        on the basis of initial screening task scores. Subjects are requested to participate for at&#xD;
        least 150 min per week in app interaction activities for up to 8 weeks with measures&#xD;
        primarily evaluating feasibility of app package task completion, and secondarily evaluating&#xD;
        the cognitive effect of these activities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 18, 2022</start_date>
    <completion_date type="Actual">March 27, 2023</completion_date>
    <primary_completion_date type="Actual">March 15, 2023</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Technical Feasibility (Task Completion)</measure>
      <time_frame>Weekly, for 8 weeks</time_frame>
      <description>Number of interaction trials completed (measured as whole number count, per subject, per week)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Task Performance</measure>
      <time_frame>Weekly, for 8 weeks</time_frame>
      <description>Baseline (Enrollment) and Postintervention (Week 8)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability Rating</measure>
      <time_frame>Once, at 8 weeks</time_frame>
      <description>DFS UX survey (assessed by Likert scale, 1-5 whole number response per question)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">124</enrollment>
    <condition>Cognitive Function Abnormal</condition>
    <arm_group>
      <arm_group_label>Cognition exercises group I</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cognition exercises group C</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>mHealth application (custom)</intervention_name>
      <description>Smartphone based application designed to engage user executive functions</description>
      <arm_group_label>Cognition exercises group C</arm_group_label>
      <arm_group_label>Cognition exercises group I</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years and above&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
            -  Resides in the United States&#xD;
  &#xD;
            -  Score on prescreen task is in 25% quartile&#xD;
  &#xD;
            -  Familiar with smartphone device app installation and device usage&#xD;
  &#xD;
            -  Possesses a compatible smartphone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Travis Smith</last_name>
      <role>Study Director</role>
      <affiliation>Kansas State</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kansas State DPS</name>
        <address>
          <city>Manhattan</city>
          <state>Kansas</state>
          <zip>66506</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cognition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990335
  org study id: NX-21270
  nct id: NCT05990335
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is designed to to test the technical feasibility of encouraging interaction with a
        mobile smartphone software package (mHealth app) for training aspects of executive function
        and cognition.
  The purpose of this human subjects study is to test the technical feasibility of interaction
        with a mobile smartphone software package (mHealth app) for training in aspects of executive
        function and cognition. The study participants are healthy subjects recruited online, with
        consent secured at the time of screening, and with enrollees assigned to High or Low groups
        on the basis of initial screening task scores. Subjects are requested to participate for at
        least 150 min per week in app interaction activities for up to 8 weeks with measures
        primarily evaluating feasibility of app package task completion, and secondarily evaluating
        the cognitive effect of these activities.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Technical Feasibility (Task Completion)
  time frame: Weekly, for 8 weeks
  description: Number of interaction trials completed (measured as whole number count, per subject, per week)
  measure: Task Performance
  time frame: Weekly, for 8 weeks
  description: Baseline (Enrollment) and Postintervention (Week 8)
  measure: Usability Rating
  time frame: Once, at 8 weeks
  description: DFS UX survey (assessed by Likert scale, 1-5 whole number response per question)
  arm group label: Cognition exercises group I
  arm group type: Experimental
  description: Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions
  arm group label: Cognition exercises group C
  arm group type: Active Comparator
  description: Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions
  intervention type: Behavioral
  intervention name: mHealth application (custom)
  description: Smartphone based application designed to engage user executive functions
  arm group label: Cognition exercises group C
  arm group label: Cognition exercises group I
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Travis Smith
  role: Study Director
  affiliation: Kansas State
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  sharing ipd: No