<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/NCT03272763</url>
  </required_header>
  <id_info>
    <org_study_id>CIA-225</org_study_id>
    <nct_id>NCT03272763</nct_id>
  </id_info>
  <brief_title>A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea</brief_title>
  <official_title>A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation is designed to evaluate the comfort, ease of use and performance of a&#xD;
      trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA&#xD;
      participants who currently use a full-face mask will be recruited.&#xD;
&#xD;
      This study will involve a baseline (Visit One) data gathering with the participant's positive&#xD;
      airway pressure (PAP) therapy and their usual mask. This will be followed by the participants&#xD;
      being fitted with the trial full-face mask for use in-home (Visit Two).&#xD;
&#xD;
      The participant then will come in to return the mask (Visit Three) and give their feedback on&#xD;
      their experience using the mask in home in the form of a structured interview during Visit&#xD;
      Three. The maximum amount of time the participants will be exposed to the trial mask in-home&#xD;
      will be 14 ± 5 days from Visit Two.&#xD;
&#xD;
      The mask and CPAP (if used from the research pool) will be returned to the institution at the&#xD;
      conclusion of the trial and participant will return to their usual mask and therapy device&#xD;
      for the treatment of their Obstructive Sleep Apnea.&#xD;
&#xD;
      Neither the investigators nor the participants will be blinded to the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">October 9, 2018</completion_date>
  <primary_completion_date type="Actual">October 29, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>After a period of baseline, all enrolled participants will be put on the same trial mask.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trial Mask Comfort</measure>
    <time_frame>14 ± 5 days In-Home</time_frame>
    <description>Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial Mask Performance - Objective</measure>
    <time_frame>14 ± 5 days In-Home</time_frame>
    <description>Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial Mask Performance - Subjective</measure>
    <time_frame>14 ± 5 days In-Home</time_frame>
    <description>Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial Mask Usability</measure>
    <time_frame>During Visit Two - 20 minutes</time_frame>
    <description>Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial Mask Ease-of-Use</measure>
    <time_frame>14 ± 5 days In-Home</time_frame>
    <description>Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mask Leak Data</measure>
    <time_frame>14 ± 5 days In-Home</time_frame>
    <description>Leak data recorded from PAP device - Objective</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seal Size Determination</measure>
    <time_frame>1 day-time appointment (1 hour) during Visit Two</time_frame>
    <description>Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy Data</measure>
    <time_frame>14 ± 5 days In-Home</time_frame>
    <description>AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>F&amp;P Toffee mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>F&amp;P Toffee mask</intervention_name>
    <description>Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
    <arm_group_label>F&amp;P Toffee mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AHI ≥ 5 from the diagnostic night&#xD;
&#xD;
          -  Aged 22 and over (FDA defined as default)&#xD;
&#xD;
          -  Either prescribed APAP, CPAP or Bi-level PAP for OSA&#xD;
&#xD;
          -  Existing Full-Face mask user&#xD;
&#xD;
          -  Fluent in spoken and written English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Participant intolerant to PAP&#xD;
&#xD;
          -  Anatomical or physiological conditions making PAP therapy inappropriate&#xD;
&#xD;
          -  Current diagnosis of respiratory disease or CO2 retention&#xD;
&#xD;
          -  Pregnant or think they may be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>California Sleep Solutions</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>April 25, 2022</results_first_submitted>
  <results_first_submitted_qc>May 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2022</results_first_posted>
  <disposition_first_submitted>February 7, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>May 25, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 21, 2022</disposition_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</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>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be available to other researchers or institutions. Identifiable participant data will not leave the site and all other data will be de-identified.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03272763/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>F&amp;P Toffee Mask</title>
          <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>F&amp;P Toffee Mask</title>
          <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
          </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="38"/>
                  </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>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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Comfort</title>
        <description>Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective</description>
        <time_frame>14 ± 5 days In-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Comfort</title>
          <description>Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Much better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Same</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Performance - Objective</title>
        <description>Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective</description>
        <time_frame>14 ± 5 days In-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Performance - Objective</title>
          <description>Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increased leak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Same leak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreased leak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Performance - Subjective</title>
        <description>Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective</description>
        <time_frame>14 ± 5 days In-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Performance - Subjective</title>
          <description>Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Much better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Same</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Usability</title>
        <description>Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective</description>
        <time_frame>During Visit Two - 20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Usability</title>
          <description>Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Both orientation and positioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orientation only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Ease-of-Use</title>
        <description>Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective</description>
        <time_frame>14 ± 5 days In-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Ease-of-Use</title>
          <description>Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Much better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Same</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mask Leak Data</title>
        <description>Leak data recorded from PAP device - Objective</description>
        <time_frame>14 ± 5 days In-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Mask Leak Data</title>
          <description>Leak data recorded from PAP device - Objective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leak increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leak remained the same</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leak decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seal Size Determination</title>
        <description>Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.</description>
        <time_frame>1 day-time appointment (1 hour) during Visit Two</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Seal Size Determination</title>
          <description>Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy Data</title>
        <description>AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective</description>
        <time_frame>14 ± 5 days In-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>F&amp;P Toffee Mask</title>
            <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy Data</title>
          <description>AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AHI increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AHI remained the same</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AHI decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>F&amp;P Toffee Mask</title>
          <description>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.&#xD;
F&amp;P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.</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="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion and sore</sub_title>
                <description>Facial pressure sore on bridge of nose, sinus infection</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </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>There IS 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>Rebecca Thomson</name_or_title>
      <organization>Fisher &amp; Paykel Healthcare Ltd.</organization>
      <phone>+64 9 574 0123 ext 7675</phone>
      <email>Rebecca.Thomson@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/NCT03272763
org study id: CIA-225
nct id: NCT03272763
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This investigation is designed to evaluate the comfort, ease of use and performance of a
      trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA
      participants who currently use a full-face mask will be recruited.

      This study will involve a baseline (Visit One) data gathering with the participant's positive
      airway pressure (PAP) therapy and their usual mask. This will be followed by the participants
      being fitted with the trial full-face mask for use in-home (Visit Two).

      The participant then will come in to return the mask (Visit Three) and give their feedback on
      their experience using the mask in home in the form of a structured interview during Visit
      Three. The maximum amount of time the participants will be exposed to the trial mask in-home
      will be 14 ± 5 days from Visit Two.

      The mask and CPAP (if used from the research pool) will be returned to the institution at the
      conclusion of the trial and participant will return to their usual mask and therapy device
      for the treatment of their Obstructive Sleep Apnea.

      Neither the investigators nor the participants will be blinded to the study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: After a period of baseline, all enrolled participants will be put on the same trial mask.
primary purpose: Treatment
masking: None (Open Label)
measure: Trial Mask Comfort
time frame: 14 ± 5 days In-Home
description: Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
measure: Trial Mask Performance - Objective
time frame: 14 ± 5 days In-Home
description: Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
measure: Trial Mask Performance - Subjective
time frame: 14 ± 5 days In-Home
description: Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
measure: Trial Mask Usability
time frame: During Visit Two - 20 minutes
description: Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
measure: Trial Mask Ease-of-Use
time frame: 14 ± 5 days In-Home
description: Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
measure: Mask Leak Data
time frame: 14 ± 5 days In-Home
description: Leak data recorded from PAP device - Objective
measure: Seal Size Determination
time frame: 1 day-time appointment (1 hour) during Visit Two
description: Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
measure: Efficacy Data
time frame: 14 ± 5 days In-Home
description: AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
arm group label: F&P Toffee mask
arm group type: Experimental
description: Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
intervention type: Device
intervention name: F&P Toffee mask
description: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
arm group label: F&P Toffee mask
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No
ipd description: Individual participant data will not be available to other researchers or institutions. Identifiable participant data will not leave the site and all other data will be de-identified.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 