<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/NCT02238028</url>
  </required_header>
  <id_info>
    <org_study_id>KZGY 001</org_study_id>
    <nct_id>NCT02238028</nct_id>
  </id_info>
  <brief_title>Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators</brief_title>
  <official_title>Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators: a Randomized Controlled Crossover Trial Among Healthy Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An intervention study to assess the short-term cardiovascular effects of reducing personal&#xD;
      air pollution exposure by wearing particulate filtering respirators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A group of healthy adult college students fulfilling the recruitment criteria were randomly&#xD;
      divided into two sub-groups. One sub-group weared the particulate filtering respirators for 2&#xD;
      continuous days during which the respirator was required to wear as much as possible both&#xD;
      indoor and outdoor. The other group acted as normal at the same time. The measurements on&#xD;
      health effects including heart rate varibility, blood pressure, circulating biomarkers as&#xD;
      well as the ambient air pollution were performed in both groups during the intervention&#xD;
      period. After a 3-week rest period,the two groups interchanged their roles of wearing the&#xD;
      respirator or not. The same measurements of both health effects indicators and ambient air&#xD;
      pollution were repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate Variability-LF Power,HF Power,VLF Power</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>The blood pressure were measured by automatic blood pressure monitor during the intervention study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability-SDNN,SDANN, rMSSD</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability-LF/HF</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability-pNN50</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating Biomarkers--Fibrinogen，vWF</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating Biomarkers--P- Selectin,VCAM-1</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating Biomarkers--ET-1</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Autonomic Nervous System Imbalance</condition>
  <condition>Blood Pressure</condition>
  <condition>Inflammation</condition>
  <condition>Vasoconstriction</condition>
  <condition>Blood Coagulation Disorders</condition>
  <arm_group>
    <arm_group_label>Wear respirator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not wear respirator</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wear respirator</intervention_name>
    <description>Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
    <arm_group_label>Wear respirator</arm_group_label>
    <other_name>particulate filtering respirator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Equal to or older than 18 years old,&#xD;
&#xD;
          -  No history of smoking and alcohol addiction.&#xD;
&#xD;
          -  No chronic diseases,such as hypertension,diabetes,chronic obstructive pulmonary&#xD;
             disease or other respiratory/cardiovascular diseases reported by volunteers.&#xD;
&#xD;
          -  No respiratory or allergic diseases, like asthma, rhinitis,or other allergic diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Chronic drug use due on cardiovascular or respiratory diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kan Haidong, PhD</last_name>
    <role>Study Director</role>
    <affiliation>School of Public Health，Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Environmental Health, School of Public Health, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Shah AS, Langrish JP, Nair H, McAllister DA, Hunter AL, Donaldson K, Newby DE, Mills NL. Global association of air pollution and heart failure: a systematic review and meta-analysis. Lancet. 2013 Sep 21;382(9897):1039-48. doi: 10.1016/S0140-6736(13)60898-3. Epub 2013 Jul 10.</citation>
    <PMID>23849322</PMID>
  </reference>
  <reference>
    <citation>Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.</citation>
    <PMID>26022815</PMID>
  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>October 20, 2015</results_first_submitted>
  <results_first_submitted_qc>April 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 6, 2016</results_first_posted>
  <last_update_submitted>April 6, 2016</last_update_submitted>
  <last_update_submitted_qc>April 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Haidong Kan</investigator_full_name>
    <investigator_title>Professor, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Heart rate variability</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Circulating biomarkers</keyword>
  <keyword>Respirator</keyword>
  <keyword>Fine particulate matter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wearing Respirator First,Then Not Wearing Respirator</title>
          <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
        </group>
        <group group_id="P2">
          <title>Not Wearing Respirator First,Then Wearing Respirator</title>
          <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>systolic pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>diastolic pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate Variability-LF Power,HF Power,VLF Power</title>
        <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.</description>
        <time_frame>up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Variability-LF Power,HF Power,VLF Power</title>
          <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.</description>
          <units>ms^2</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>low frequency(LF) power</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="899.4" spread="601.3"/>
                    <measurement group_id="O2" value="838.5" spread="562.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high frequency(HF) power</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="519.7" spread="371.0"/>
                    <measurement group_id="O2" value="416.6" spread="296.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>very low frequency(VLF) power</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1684.6" spread="875.7"/>
                    <measurement group_id="O2" value="1623.1" spread="1006.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Paired t-test,2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Blood Pressure</title>
        <description>The blood pressure were measured by automatic blood pressure monitor during the intervention study.</description>
        <time_frame>up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>The blood pressure were measured by automatic blood pressure monitor during the intervention study.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.3" spread="8.0"/>
                    <measurement group_id="O2" value="109.0" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" spread="5.0"/>
                    <measurement group_id="O2" value="70.8" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Paired t-test,2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate Variability-SDNN,SDANN, rMSSD</title>
        <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.</description>
        <time_frame>Up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Variability-SDNN,SDANN, rMSSD</title>
          <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.</description>
          <units>ms</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SDNN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177.5" spread="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDANN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160.7" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>rMSSD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate Variability-LF/HF</title>
        <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.</description>
        <time_frame>Up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Variability-LF/HF</title>
          <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.</description>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="0.3"/>
                    <measurement group_id="O2" value="1.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate Variability-pNN50</title>
        <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.</description>
        <time_frame>Up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Variability-pNN50</title>
          <description>HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.</description>
          <units>percentage of ms</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="9.9"/>
                    <measurement group_id="O2" value="20.5" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Circulating Biomarkers--Fibrinogen，vWF</title>
        <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)</description>
        <time_frame>Up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Biomarkers--Fibrinogen，vWF</title>
          <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)</description>
          <units>µg/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fibrinogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.3"/>
                    <measurement group_id="O2" value="2.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>vWF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" spread="1.3"/>
                    <measurement group_id="O2" value="27.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Circulating Biomarkers--P- Selectin,VCAM-1</title>
        <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)</description>
        <time_frame>Up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Biomarkers--P- Selectin,VCAM-1</title>
          <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)</description>
          <units>ng/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>P-selectin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.0" spread="2.0"/>
                    <measurement group_id="O2" value="200.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VCAM-1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1480.3" spread="1.5"/>
                    <measurement group_id="O2" value="1808.0" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Circulating Biomarkers--ET-1</title>
        <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.</description>
        <time_frame>Up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
          </group>
          <group group_id="O2">
            <title>Not Wear Respirator</title>
            <description>The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Biomarkers--ET-1</title>
          <description>At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.</description>
          <units>pg/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.9" spread="1.6"/>
                    <measurement group_id="O2" value="121.5" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At the end of each 2-day period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wear Respirator</title>
          <description>The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.&#xD;
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.</description>
        </group>
        <group group_id="E2">
          <title>Not Wear Respirator</title>
          <description>The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Haidong Kan</name_or_title>
      <organization>Fudan University</organization>
      <phone>+86-021-54237908</phone>
      <email>kanh@fudan.edu.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02238028
org study id: KZGY 001
nct id: NCT02238028
lead sponsor: 
has dmc: Yes
An intervention study to assess the short-term cardiovascular effects of reducing personal
      air pollution exposure by wearing particulate filtering respirators.
A group of healthy adult college students fulfilling the recruitment criteria were randomly
      divided into two sub-groups. One sub-group weared the particulate filtering respirators for 2
      continuous days during which the respirator was required to wear as much as possible both
      indoor and outdoor. The other group acted as normal at the same time. The measurements on
      health effects including heart rate varibility, blood pressure, circulating biomarkers as
      well as the ambient air pollution were performed in both groups during the intervention
      period. After a 3-week rest period,the two groups interchanged their roles of wearing the
      respirator or not. The same measurements of both health effects indicators and ambient air
      pollution were repeated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Heart Rate Variability-LF Power,HF Power,VLF Power
time frame: up to 24 hours
description: HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.
measure: Blood Pressure
time frame: up to 24 hours
description: The blood pressure were measured by automatic blood pressure monitor during the intervention study.
measure: Heart Rate Variability-SDNN,SDANN, rMSSD
time frame: Up to 24 hours
description: HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.
measure: Heart Rate Variability-LF/HF
time frame: Up to 24 hours
description: HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.
measure: Heart Rate Variability-pNN50
time frame: Up to 24 hours
description: HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.
measure: Circulating Biomarkers--Fibrinogen，vWF
time frame: Up to 24 hours
description: At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)
measure: Circulating Biomarkers--P- Selectin,VCAM-1
time frame: Up to 24 hours
description: At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)
measure: Circulating Biomarkers--ET-1
time frame: Up to 24 hours
description: At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.
arm group label: Wear respirator
arm group type: Experimental
description: The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
arm group label: Not wear respirator
arm group type: No Intervention
description: The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
intervention type: Behavioral
intervention name: Wear respirator
description: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.
arm group label: Wear respirator
other name: particulate filtering respirator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kan Haidong, PhD
role: Study Director
affiliation: School of Public Health，Fudan University
facility: 
country: China
citation: Shah AS, Langrish JP, Nair H, McAllister DA, Hunter AL, Donaldson K, Newby DE, Mills NL. Global association of air pollution and heart failure: a systematic review and meta-analysis. Lancet. 2013 Sep 21;382(9897):1039-48. doi: 10.1016/S0140-6736(13)60898-3. Epub 2013 Jul 10.
PMID: 23849322
citation: Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.
PMID: 26022815
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Haidong Kan
investigator title: Professor, Ph.D.
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Inflammation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 