<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/NCT03301402</url>
  </required_header>
  <id_info>
    <org_study_id>2017.304</org_study_id>
    <nct_id>NCT03301402</nct_id>
  </id_info>
  <brief_title>Air Purifier to Improve Endothelial Function and Carotid Intima Thickness</brief_title>
  <official_title>A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: There is epidemiological evidence or link ambient air pollution exposure to the&#xD;
      incidence of dementia.&#xD;
&#xD;
      Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air&#xD;
      purification improves endothelial function and carotid intima thickness in older diabetic&#xD;
      people with cognitive impairment.&#xD;
&#xD;
      Subjects and method: People with clinically diagnosis mild cognitive impairment or early&#xD;
      dementia will be recruited. After obtaining written consent, the subjects will be assessed&#xD;
      cognitive function and arterial health. After baseline measurements, the subjects are&#xD;
      randomly assigned to have either filter or no filter installed in the air purifier. The air&#xD;
      purifier will be placed in living room of the household of the subject for one year. At one&#xD;
      year, the measurements will be repeated.&#xD;
&#xD;
      Statistical analysis: Intention to treat analysis will be adopted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">January 5, 2021</completion_date>
  <primary_completion_date type="Actual">January 5, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FMD%</measure>
    <time_frame>12 months</time_frame>
    <description>Endothelial function will be assessed by Flow mediated dilatation of brachial artery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Endothelial Function</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Filter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No filter</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air purifier</intervention_name>
    <description>Air purifier with filter at automatic mode on all time</description>
    <arm_group_label>Filter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic people&#xD;
&#xD;
          -  Mild cognitive impairment or early dementia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  The presence of a smoker in the household&#xD;
&#xD;
          -  The absence of a reliable family caregiver&#xD;
&#xD;
          -  The lack of mental capacity to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy Kwok</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Timothy Kwok</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03301402
org study id: 2017.304
nct id: NCT03301402
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: There is epidemiological evidence or link ambient air pollution exposure to the
      incidence of dementia.

      Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air
      purification improves endothelial function and carotid intima thickness in older diabetic
      people with cognitive impairment.

      Subjects and method: People with clinically diagnosis mild cognitive impairment or early
      dementia will be recruited. After obtaining written consent, the subjects will be assessed
      cognitive function and arterial health. After baseline measurements, the subjects are
      randomly assigned to have either filter or no filter installed in the air purifier. The air
      purifier will be placed in living room of the household of the subject for one year. At one
      year, the measurements will be repeated.

      Statistical analysis: Intention to treat analysis will be adopted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: FMD%
time frame: 12 months
description: Endothelial function will be assessed by Flow mediated dilatation of brachial artery
arm group label: Filter
arm group type: Active Comparator
arm group label: No filter
arm group type: No Intervention
intervention type: Device
intervention name: Air purifier
description: Air purifier with filter at automatic mode on all time
arm group label: Filter
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy Kwok
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Timothy Kwok
investigator title: Professor
mesh term: Cognitive Dysfunction