<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/NCT02230085</url>
  </required_header>
  <id_info>
    <org_study_id>CIA-121</org_study_id>
    <nct_id>NCT02230085</nct_id>
  </id_info>
  <brief_title>Adherence Risk Indicator Validation Study</brief_title>
  <acronym>ARI</acronym>
  <official_title>A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fisher and Paykel Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      While continuous positive airway pressure (CPAP) is the gold standard treatment of&#xD;
      obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The&#xD;
      adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire.&#xD;
      The data collected from this trail allows for closer monitoring of at-risk patients. For the&#xD;
      study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA.&#xD;
      Participants will be provided with a GSM (Global System for Mobile communication) modem to&#xD;
      allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30&#xD;
      and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the&#xD;
      GSM unit is returned, and participants continue with CPAP therapy as instructed by their&#xD;
      healthcare provider.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CPAP Therapy Adherence</measure>
    <time_frame>90 days</time_frame>
    <description>Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>CPAP therapy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Administration of the questionnaire and monitoring of CPAP adherence</intervention_name>
    <arm_group_label>CPAP therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient recieving CPAP for OSA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18years of age&#xD;
&#xD;
          -  Diagnosed with OSA (AHI &gt;5 events/hour) and eligible for CPAP (fixed or auto)&#xD;
             treatment under local requirements&#xD;
&#xD;
          -  Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for CPAP therapy&#xD;
&#xD;
          -  Medically unstable condition/diagnosis that is not yet under control&#xD;
&#xD;
          -  Co-existing sleep disorder (however clinically diagnosed insomnia can be included in&#xD;
             the study)&#xD;
&#xD;
          -  PLMA (Periodic Limb Movement Activity) Index greater than 15/hr&#xD;
&#xD;
          -  Home titration of longer than 5 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EverythingCPAP</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>October 11, 2016</results_first_submitted>
  <results_first_submitted_qc>October 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 2, 2016</results_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CPAP Therapy</title>
          <description>Administration of the questionnaire and monitoring of CPAP adherence</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CPAP Therapy</title>
          <description>Administration of the questionnaire and monitoring of CPAP adherence</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="103"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" lower_limit="27" upper_limit="73"/>
                  </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="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CPAP Therapy Adherence</title>
        <description>Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.</description>
        <time_frame>90 days</time_frame>
        <population>103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.</population>
        <group_list>
          <group group_id="O1">
            <title>CPAP Therapy</title>
            <description>Administration of the questionnaire and monitoring of CPAP adherence</description>
          </group>
        </group_list>
        <measure>
          <title>CPAP Therapy Adherence</title>
          <description>Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.</description>
          <population>103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over 90 days for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CPAP Therapy</title>
          <description>Administration of the questionnaire and monitoring of CPAP adherence</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
              </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="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for an undescribed period .</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research Scientist</name_or_title>
      <organization>Fisher &amp; Paykel Healthcare</organization>
      <phone>+6495740123</phone>
      <email>cpaptrial@fphcare.co.nz</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/NCT02230085
org study id: CIA-121
nct id: NCT02230085
lead sponsor: 
has dmc: No
While continuous positive airway pressure (CPAP) is the gold standard treatment of
      obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The
      adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire.
      The data collected from this trail allows for closer monitoring of at-risk patients. For the
      study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA.
      Participants will be provided with a GSM (Global System for Mobile communication) modem to
      allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30
      and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the
      GSM unit is returned, and participants continue with CPAP therapy as instructed by their
      healthcare provider.
observational model: Cohort
time perspective: Prospective
measure: CPAP Therapy Adherence
time frame: 90 days
description: Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.
arm group label: CPAP therapy
intervention type: Other
intervention name: Administration of the questionnaire and monitoring of CPAP adherence
arm group label: CPAP therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 