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/NCT05994937</url>
    </required_header>
    <id_info>
      <org_study_id>23-00755</org_study_id>
      <nct_id>NCT05994937</nct_id>
    </id_info>
    <brief_title>Cleaner Air for Lower Cardiometabolic Risk</brief_title>
    <official_title>Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Doris Duke Charitable Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>NYU Langone Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this interventional sham-controlled pilot study is to study the effects of&#xD;
        using portable air cleaners (PACs) in outpatient adults with prediabetes. The primary aims&#xD;
        are to determine the effect PAC's have on glycemic variability and the concentrations of&#xD;
        circulating biomarkers of inflammation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)</measure>
      <time_frame>Baseline, Week 4</time_frame>
      <description>A CGM will be placed at baseline to continuously measure glucose, which will then be used to assess glycemic variability at the end of 4 weeks post-intervention. This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent Change of C-reactive Protein (CRP) Biomarkers</measure>
      <time_frame>Baseline, Week 4</time_frame>
      <description>This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers</measure>
      <time_frame>Baseline, Week 4</time_frame>
      <description>This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers</measure>
      <time_frame>Baseline, Week 4</time_frame>
      <description>This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">142</enrollment>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>Active Portable Air Cleaner (PAC) Filtration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Portable Air Cleaner (PAC) Filtration</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PAC with HEPA filter intact</intervention_name>
      <description>A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.</description>
      <arm_group_label>Active Portable Air Cleaner (PAC) Filtration</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PAC with HEPA filter removed</intervention_name>
      <description>Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.</description>
      <arm_group_label>Sham Portable Air Cleaner (PAC) Filtration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant is ≥18 years old&#xD;
  &#xD;
            -  Participant and members of household are reported to be non-smokers (defined as no&#xD;
               household members are currently known to smoke cigarettes or use other tobacco&#xD;
               products including e-cigarettes)&#xD;
  &#xD;
            -  Participant is to understand/speak English or Spanish&#xD;
  &#xD;
            -  Participant can understand study procedures and give informed consent&#xD;
  &#xD;
            -  Participant has prediabetes, defined as the absence of diabetes and any of the&#xD;
               following: fasting plasma glucose 100-125 mg/dL, 2 hour plasma glucose of 140-199&#xD;
               mg/dL after 75 g oral glucose tolerance test, or A1c 5.7- 6.4%.&#xD;
  &#xD;
            -  Able to wear CGM for 2 two-week periods&#xD;
  &#xD;
            -  Able to participate in telephone or video conference for home equipment setup if&#xD;
               needed&#xD;
  &#xD;
            -  Able to visit clinic for blood draws before and after the study period&#xD;
  &#xD;
            -  Do not intend to sleep anywhere outside of primary bedroom for more than 48&#xD;
               consecutive hours or a total of 7 days during the study period.&#xD;
  &#xD;
            -  Ability to lift, or access to assistance with lifting, 20 lb to set up air filter&#xD;
               appliance in bedroom.&#xD;
  &#xD;
            -  Have not undergone major dietary change (such as change from usual diet to&#xD;
               intermittent fasting or caloric restriction) in the past 2 weeks, and do not intend to&#xD;
               during the study period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who have diagnosed diabetes, or take antihyperglycemic medications&#xD;
  &#xD;
            -  Participants with known atherosclerotic disease: coronary artery disease, peripheral&#xD;
               artery disease or history of cerebrovascular disease (stroke or Transient Ischemic&#xD;
               Attack (TIA), carotid stenosis)&#xD;
  &#xD;
            -  Participants with known systemic inflammatory conditions (including but not limited&#xD;
               to: inflammatory arthritis, vasculitides, inflammatory bowel diseases, cancer within&#xD;
               past 5 years, Hashimoto's thyroiditis)&#xD;
  &#xD;
            -  Participants currently taking any anti-inflammatory medications or medications that&#xD;
               target inflammatory cytokines&#xD;
  &#xD;
            -  Pregnancy: because blood glucose problems during pregnancy require intensive&#xD;
               monitoring and lifestyle changes to protect the mother and fetus&#xD;
  &#xD;
            -  Participants with known or suspected Covid-19 in the prior 30 days&#xD;
  &#xD;
            -  Participants with post-covid sequelae (a.k.a &quot;Long covid&quot;)&#xD;
  &#xD;
            -  Participants who are already utilizing HEPA filtration (PAC or within HVAC) in&#xD;
               bedrooms&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jonathan Newman</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sharine Wittkopp</last_name>
      <phone>646-501-8121</phone>
      <email>Sharine.Wittkopp@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jonathan Newman</last_name>
      <phone>212-263-9393</phone>
      <email>Jonathan.Newman@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Medical Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</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>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Air pollution</keyword>
    <keyword>prediabetes</keyword>
    <keyword>inflammation</keyword>
    <keyword>cardiovascular disease prevention</keyword>
    <keyword>blood sugar</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
      <mesh_term>Glucose Intolerance</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sharine.Wittkopp@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
      <ipd_access_criteria>The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Sharine.Wittkopp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </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/NCT05994937
  org study id: 23-00755
  nct id: NCT05994937
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this interventional sham-controlled pilot study is to study the effects of
        using portable air cleaners (PACs) in outpatient adults with prediabetes. The primary aims
        are to determine the effect PAC's have on glycemic variability and the concentrations of
        circulating biomarkers of inflammation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
  time frame: Baseline, Week 4
  description: A CGM will be placed at baseline to continuously measure glucose, which will then be used to assess glycemic variability at the end of 4 weeks post-intervention. This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
  measure: Percent Change of C-reactive Protein (CRP) Biomarkers
  time frame: Baseline, Week 4
  description: This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
  measure: Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers
  time frame: Baseline, Week 4
  description: This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
  measure: Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers
  time frame: Baseline, Week 4
  description: This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
  arm group label: Active Portable Air Cleaner (PAC) Filtration
  arm group type: Experimental
  description: High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.
  arm group label: Sham Portable Air Cleaner (PAC) Filtration
  arm group type: Sham Comparator
  description: High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.
  intervention type: Device
  intervention name: PAC with HEPA filter intact
  description: A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
  arm group label: Active Portable Air Cleaner (PAC) Filtration
  intervention type: Device
  intervention name: PAC with HEPA filter removed
  description: Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
  arm group label: Sham Portable Air Cleaner (PAC) Filtration
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Jonathan Newman
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Sharine Wittkopp
  phone: 646-501-8121
  email: Sharine.Wittkopp@nyulangone.org
  last name: Jonathan Newman
  phone: 212-263-9393
  email: Jonathan.Newman@nyulangone.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prediabetic State
  mesh term: Glucose Intolerance
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sharine.Wittkopp@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
  ipd access criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Sharine.Wittkopp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.