<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/NCT03762239</url>
  </required_header>
  <id_info>
    <org_study_id>PI2030</org_study_id>
    <nct_id>NCT03762239</nct_id>
  </id_info>
  <brief_title>Effect of Air Pollution on the Cognitive Function of Adolescents</brief_title>
  <acronym>ATENC!Ó</acronym>
  <official_title>Citizen Science for Analysing the Effect of Air Pollution on the Cognitive Function of Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelona Institute for Global Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Recercaixa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de Recerca per a l'Educació Científica i Matemàtica (CRECIM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Environmental Assessment and Water Research (IDAEA-CSIC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Economics and Bussiness Department, Universtitat Pompeu Fabra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barcelona Institute for Global Health</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>
      Previous observational studies have reported an association between higher air pollution&#xD;
      exposure and lower attention in children. With this project, the investigators aim to confirm&#xD;
      this association in adolescents using an experimental design. In addition, the study will&#xD;
      assess the relationship between air pollution exposure and individual preferences with&#xD;
      respect to risk, time and social considerations. High school students in 3rd grade (ESO,&#xD;
      14-15 years of age) in different high schools in the Barcelona province (Spain) will be&#xD;
      invited to participate. For each class in each high school, participating students will be&#xD;
      randomly split into two equal-sized groups. Each group will be assigned to a different&#xD;
      classroom where they will complete several activities during two hours, including an&#xD;
      attention test (Flanker task) and a reduced version of the Global Preferences Survey. One of&#xD;
      the classrooms will have an air purifier that will clean the air. The other classroom will&#xD;
      have the same device but without the filters, so it will only re-circulate the air without&#xD;
      cleaning it. Students will be masked to intervention allocation. The investigators&#xD;
      hypothesize that students assigned to the clean air classroom will have better scores in the&#xD;
      attention test, and that decision-making will also present differences in the two classrooms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2018</start_date>
  <completion_date type="Actual">June 11, 2019</completion_date>
  <primary_completion_date type="Actual">June 11, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response speed consistency throughout the Attention Network Task-Flanker Task (post ANT)</measure>
    <time_frame>Obtained from a test administered approximately 90 minutes after entering the classroom</time_frame>
    <description>Calculated as hit reaction time standard error for correct responses (HRT-SE). A higher HRT-SE indicates highly variable reactions related to inattentiveness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Combined risk taking score</measure>
    <time_frame>Obtained from a test administered approximately 100 minutes after entering the classroom</time_frame>
    <description>Risk taking = 0.4729985 × &quot;Risk preference score&quot; + 0.5270015 × &quot;Willingness to take risks&quot;, that follows the parameters of Falk et al (2018), where the &quot;Risk preference score&quot; is the final node in the risk tree (see the online appendix of Falk et al (2018)), which is a value between 1 and 32, ranked by the level of risk aversion, and the &quot;Willingness to take risks&quot; refers to the answer to the question on one's willingness to take risks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Combined patience score</measure>
    <time_frame>Obtained from a test administered approximately 100 minutes after entering the classroom</time_frame>
    <description>Patience = 0.7115185 × &quot;Time preference score&quot; + 0.2884815 × &quot;Self assessment of patience&quot;, that follows the parameters of Falk et al (2018), where the &quot;Time preference score&quot; is the final node in the time tree (see the online appendix of Falk et al (2018)), which is a value between 1 and 32, ranked by the level of patience, and the &quot;Self assessment of patience&quot; refers to the answer to the question on the self-assessment of patience (willingness to give up something today).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive reciprocity score</measure>
    <time_frame>Obtained from a test administered approximately 100 minutes after entering the classroom</time_frame>
    <description>Positive reciprocity = 0.4847038 × &quot;Willingness to return favor&quot; + 0.5152962 × &quot;Size of gift&quot;, that follows the parameters of Falk et al (2018), where &quot;Willingness to return favor&quot; refers to the answer to the question on the willingness to return a favor, and &quot;Size of gift&quot; refers to the answer to the question on the reported size of the gift that would return to a stranger.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Altruism score</measure>
    <time_frame>Obtained from a test administered approximately 100 minutes after entering the classroom</time_frame>
    <description>Altruism = 0.6350048 × &quot;Willingness to give to good causes&quot; + 0.3649952 × &quot;Hypothetical donation&quot;, that follows the parameters of Falk et al (2018), where &quot;Willingness to give to good causes&quot; refers to the answer to the question on the willingness to give to good causes, and &quot;Hypothetical donation&quot; refers to the answer to the question on the size of the hypothetical donation one would be willing to make.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trust score</measure>
    <time_frame>Obtained from a test administered approximately 100 minutes after entering the classroom</time_frame>
    <description>Answer to the question &quot;I assume that people have only the best intentions&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impulsivity (from ANT)</measure>
    <time_frame>Obtained from a test administered approximately 90 minutes after entering the classroom</time_frame>
    <description>Number of incorrect responses (responses made in the opposite direction to the direction of the target arrow)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Selective attention (from ANT)</measure>
    <time_frame>Obtained from a test administered approximately 90 minutes after entering the classroom</time_frame>
    <description>Number of omission errors (failure to respond)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alerting score (from ANT)</measure>
    <time_frame>Obtained from a test administered approximately 90 minutes after entering the classroom</time_frame>
    <description>Subtracting the median RT for double cue from median RT for the no cue condition (calculations performed after removing the incongruent trials)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orienting score (from ANT)</measure>
    <time_frame>Obtained from a test administered approximately 90 minutes after entering the classroom</time_frame>
    <description>Subtracting the median RT for spatial cue from the RT for central cue (calculations performed after removing the incongruent trials)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conflict score (executive attention) (from ANT)</measure>
    <time_frame>Obtained from a test administered approximately 90 minutes after entering the classroom</time_frame>
    <description>Participant's median RT for each flanker condition (across cue conditions) and subtracted the congruent from the incongruent RTs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self assessment of how good they are in math</measure>
    <time_frame>Obtained from a test administered approximately 100 minutes after entering the classroom</time_frame>
    <description>Answer to the question on how good they are in math.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2123</enrollment>
  <condition>Attention Impaired</condition>
  <condition>Risk-Taking</condition>
  <condition>Risk Behavior</condition>
  <condition>Social Preferences</condition>
  <condition>Decision Making</condition>
  <condition>Attention</condition>
  <arm_group>
    <arm_group_label>Purified air</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Purifying the air with a Pure Airbox device (Zonair 3D). Use of air purifier (Pure Airbox, Zonair 3D) in the classroom 30 minutes before the participants enter the room and during the 2 hours of the experiment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal air</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Using a sham air purifier (same device without filters). Use of the same air purifier but without filters, so that it only recirculates the air without purifying it. Used for the same time period than the other arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Purifying the air with a Pure Airbox device (Zonair 3D)</intervention_name>
    <description>Purifying the air of the classroom where the experiment is conducted using a Pure Airbox device (Zonair 3D)</description>
    <arm_group_label>Purified air</arm_group_label>
    <other_name>Air filtering</other_name>
    <other_name>Air cleaning</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Using a sham air purifier (same device without filters)</intervention_name>
    <description>Use the air purifier (Pure Airbox, Zonair 3D) without filters in the classroom where the experiment is conducted</description>
    <arm_group_label>Normal air</arm_group_label>
    <other_name>Sham air cleaner</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students in the 3rd ESO course in participating high schools with signed informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Basagaña, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barcelona Institute for Global Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ISGlobal</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention</keyword>
  <keyword>Air pollution</keyword>
  <keyword>Black carbon</keyword>
  <keyword>Particulate matter</keyword>
  <keyword>Risk behavior</keyword>
  <keyword>Social preferences</keyword>
  <keyword>Decision making</keyword>
  <keyword>Air purifier</keyword>
  <keyword>Air cleaner</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD except identifying information for participants or high schools will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available when publishing the results in a scientific journal, with no time restrictions</ipd_time_frame>
    <ipd_access_criteria>Access to anyone via a public repository</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03762239/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03762239/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>July 8, 2021</submitted>
    <returned>July 29, 2021</returned>
    <submitted>December 16, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03762239
org study id: PI2030
nct id: NCT03762239
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous observational studies have reported an association between higher air pollution
      exposure and lower attention in children. With this project, the investigators aim to confirm
      this association in adolescents using an experimental design. In addition, the study will
      assess the relationship between air pollution exposure and individual preferences with
      respect to risk, time and social considerations. High school students in 3rd grade (ESO,
      14-15 years of age) in different high schools in the Barcelona province (Spain) will be
      invited to participate. For each class in each high school, participating students will be
      randomly split into two equal-sized groups. Each group will be assigned to a different
      classroom where they will complete several activities during two hours, including an
      attention test (Flanker task) and a reduced version of the Global Preferences Survey. One of
      the classrooms will have an air purifier that will clean the air. The other classroom will
      have the same device but without the filters, so it will only re-circulate the air without
      cleaning it. Students will be masked to intervention allocation. The investigators
      hypothesize that students assigned to the clean air classroom will have better scores in the
      attention test, and that decision-making will also present differences in the two classrooms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Response speed consistency throughout the Attention Network Task-Flanker Task (post ANT)
time frame: Obtained from a test administered approximately 90 minutes after entering the classroom
description: Calculated as hit reaction time standard error for correct responses (HRT-SE). A higher HRT-SE indicates highly variable reactions related to inattentiveness
measure: Combined risk taking score
time frame: Obtained from a test administered approximately 100 minutes after entering the classroom
description: Risk taking = 0.4729985 × "Risk preference score" + 0.5270015 × "Willingness to take risks", that follows the parameters of Falk et al (2018), where the "Risk preference score" is the final node in the risk tree (see the online appendix of Falk et al (2018)), which is a value between 1 and 32, ranked by the level of risk aversion, and the "Willingness to take risks" refers to the answer to the question on one's willingness to take risks.
measure: Combined patience score
time frame: Obtained from a test administered approximately 100 minutes after entering the classroom
description: Patience = 0.7115185 × "Time preference score" + 0.2884815 × "Self assessment of patience", that follows the parameters of Falk et al (2018), where the "Time preference score" is the final node in the time tree (see the online appendix of Falk et al (2018)), which is a value between 1 and 32, ranked by the level of patience, and the "Self assessment of patience" refers to the answer to the question on the self-assessment of patience (willingness to give up something today).
measure: Positive reciprocity score
time frame: Obtained from a test administered approximately 100 minutes after entering the classroom
description: Positive reciprocity = 0.4847038 × "Willingness to return favor" + 0.5152962 × "Size of gift", that follows the parameters of Falk et al (2018), where "Willingness to return favor" refers to the answer to the question on the willingness to return a favor, and "Size of gift" refers to the answer to the question on the reported size of the gift that would return to a stranger.
measure: Altruism score
time frame: Obtained from a test administered approximately 100 minutes after entering the classroom
description: Altruism = 0.6350048 × "Willingness to give to good causes" + 0.3649952 × "Hypothetical donation", that follows the parameters of Falk et al (2018), where "Willingness to give to good causes" refers to the answer to the question on the willingness to give to good causes, and "Hypothetical donation" refers to the answer to the question on the size of the hypothetical donation one would be willing to make.
measure: Trust score
time frame: Obtained from a test administered approximately 100 minutes after entering the classroom
description: Answer to the question "I assume that people have only the best intentions".
measure: Impulsivity (from ANT)
time frame: Obtained from a test administered approximately 90 minutes after entering the classroom
description: Number of incorrect responses (responses made in the opposite direction to the direction of the target arrow)
measure: Selective attention (from ANT)
time frame: Obtained from a test administered approximately 90 minutes after entering the classroom
description: Number of omission errors (failure to respond)
measure: Alerting score (from ANT)
time frame: Obtained from a test administered approximately 90 minutes after entering the classroom
description: Subtracting the median RT for double cue from median RT for the no cue condition (calculations performed after removing the incongruent trials)
measure: Orienting score (from ANT)
time frame: Obtained from a test administered approximately 90 minutes after entering the classroom
description: Subtracting the median RT for spatial cue from the RT for central cue (calculations performed after removing the incongruent trials)
measure: Conflict score (executive attention) (from ANT)
time frame: Obtained from a test administered approximately 90 minutes after entering the classroom
description: Participant's median RT for each flanker condition (across cue conditions) and subtracted the congruent from the incongruent RTs
measure: Self assessment of how good they are in math
time frame: Obtained from a test administered approximately 100 minutes after entering the classroom
description: Answer to the question on how good they are in math.
arm group label: Purified air
arm group type: Active Comparator
description: Purifying the air with a Pure Airbox device (Zonair 3D). Use of air purifier (Pure Airbox, Zonair 3D) in the classroom 30 minutes before the participants enter the room and during the 2 hours of the experiment.
arm group label: Normal air
arm group type: Sham Comparator
description: Using a sham air purifier (same device without filters). Use of the same air purifier but without filters, so that it only recirculates the air without purifying it. Used for the same time period than the other arm.
intervention type: Other
intervention name: Purifying the air with a Pure Airbox device (Zonair 3D)
description: Purifying the air of the classroom where the experiment is conducted using a Pure Airbox device (Zonair 3D)
arm group label: Purified air
other name: Air filtering
other name: Air cleaning
intervention type: Other
intervention name: Using a sham air purifier (same device without filters)
description: Use the air purifier (Pure Airbox, Zonair 3D) without filters in the classroom where the experiment is conducted
arm group label: Normal air
other name: Sham air cleaner
criteria: 
gender: All
minimum age: 13 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xavier Basagaña, PhD
role: Principal Investigator
affiliation: Barcelona Institute for Global Health
facility: 
country: Spain
responsible party type: Sponsor
sharing ipd: Yes
ipd description: All collected IPD except identifying information for participants or high schools will be shared
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Data will become available when publishing the results in a scientific journal, with no time restrictions
ipd access criteria: Access to anyone via a public repository
provided document: 
provided document: 
submitted: July 8, 2021
returned: July 29, 2021
submitted: December 16, 2022