<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/NCT03230877</url>
  </required_header>
  <id_info>
    <org_study_id>CIA-223</org_study_id>
    <nct_id>NCT03230877</nct_id>
  </id_info>
  <brief_title>The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea</brief_title>
  <official_title>The Evaluation of a Full Face Mask Seal 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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigation is a prospective, randomized, single blinded, crossover study. The&#xD;
      investigation is designed to evaluate the performance, comfort and ease of use of the F&amp;P&#xD;
      Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number&#xD;
      of 40-45 OSA participants will be recruited for the trial by the investigation site&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will involve three visits to the investigation site. During visit one participants&#xD;
      will be randomized to, fitted with and issued with the first trial mask seal for use in- home&#xD;
      for 7 ±4 days.&#xD;
&#xD;
      The participants will then come in to return the mask seal and be fitted and issued with the&#xD;
      second trial seal for use in home for 7±4 days.&#xD;
&#xD;
      Visit Three will involve the participants returning the second trial seal and providing&#xD;
      feedback.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2017</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trial Mask Seal Comfort</measure>
    <time_frame>7 ± 4 days in-home</time_frame>
    <description>Overall seal comfort determined from questionnaires- Subjective</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial Mask Seal Acceptability</measure>
    <time_frame>14 ± 4 days in-home</time_frame>
    <description>Preference for trial mask determined from questionnaires at the end of the trial - Subjective</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trial Mask Seal Treatment Performance - Objective</measure>
    <time_frame>7 ± 4 days in-home</time_frame>
    <description>Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial Mask Seal Usability</measure>
    <time_frame>1 hour day-time appointment</time_frame>
    <description>Usability interview during first visit- Subjective</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial Mask Seal Treatment Performance- Subjective</measure>
    <time_frame>7 ± 4 days in-home</time_frame>
    <description>Seal performance determined from questionnaires - Subjective</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive either the &quot;Improved Seal&quot; or &quot;Normal Seal&quot; Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive either the &quot;Improved Seal&quot; or &quot;Normal Seal&quot; Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Toffee full face mask with 'Improved Seal'</intervention_name>
    <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Toffee full face mask with 'Normal Seal'</intervention_name>
    <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (22+ years of age)&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night&#xD;
&#xD;
          -  Either prescribed Automatic positive airway pressure (APAP), Continuous positive&#xD;
             airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA&#xD;
&#xD;
          -  Fluent in spoken and written English&#xD;
&#xD;
          -  Existing F&amp;P full face mask user&#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 carbon Dioxide (CO2) retention&#xD;
&#xD;
          -  Pregnant or may think they are 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>Clinical Trials of Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>May 26, 2022</results_first_submitted>
  <results_first_submitted_qc>August 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 8, 2022</results_first_posted>
  <disposition_first_submitted>March 19, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>August 15, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 8, 2022</disposition_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 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>This investigation is to inform product development team. Results will inform product development on the future of the product.</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>July 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03230877/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normal Seal Then Improved Seal</title>
          <description>Participants will be randomized to the Normal Seal arm for a total of 7 ± 4 days from visit 1 and then will be crossed over to the Improved Seal arm for a total of 7 ± 4 days from visit 2.</description>
        </group>
        <group group_id="P2">
          <title>Improved Seal Then Normal Seal</title>
          <description>Participants will be randomized to the Improved Seal arm for a total of 7 ± 4 days from visit 1 and then will be crossed over to the Normal Seal arm for a total of 7 ± 4 days from visit 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Visit 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Visit 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Population</title>
          <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm.</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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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 Seal Comfort</title>
        <description>Overall seal comfort determined from questionnaires- Subjective</description>
        <time_frame>7 ± 4 days in-home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Full Face Mask With 'Improved Seal'</title>
            <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.</description>
          </group>
          <group group_id="O2">
            <title>Toffee Full Face Mask With 'Normal Seal'</title>
            <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Seal Comfort</title>
          <description>Overall seal comfort 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 group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very comfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither comfortable nor uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Seal Acceptability</title>
        <description>Preference for trial mask determined from questionnaires at the end of the trial - Subjective</description>
        <time_frame>14 ± 4 days in-home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Trial Population</title>
            <description>Participants will be randomized to one arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. After both seals are trialed, participant seal preference was collected</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Seal Acceptability</title>
          <description>Preference for trial mask determined from questionnaires at the end of the trial - 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>Preferred &quot;Improved seal&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preferred &quot;Normal seal&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</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>Trial Mask Seal Treatment Performance - Objective</title>
        <description>Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data</description>
        <time_frame>7 ± 4 days in-home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Full Face Mask With &quot;Improved Seal&quot;</title>
            <description>Participants will be randomized to one arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm.</description>
          </group>
          <group group_id="O2">
            <title>Toffee Full Face Mask With &quot;Normal Seal&quot;</title>
            <description>Participants will be randomized to one arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Seal Treatment Performance - Objective</title>
          <description>Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data</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 group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increased AHI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change in AHI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreased AHI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trial Mask Seal Usability</title>
        <description>Usability interview during first visit- Subjective</description>
        <time_frame>1 hour day-time appointment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Full Face Mask With 'Improved Seal'</title>
            <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.</description>
          </group>
          <group group_id="O2">
            <title>Toffee Full Face Mask With 'Normal Seal'</title>
            <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Seal Usability</title>
          <description>Usability interview during first visit- 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 group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very easy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither easy nor difficult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very difficult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trial Mask Seal Treatment Performance- Subjective</title>
        <description>Seal performance determined from questionnaires - Subjective</description>
        <time_frame>7 ± 4 days in-home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Full Face Mask With 'Improved Seal'</title>
            <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.</description>
          </group>
          <group group_id="O2">
            <title>Toffee Full Face Mask With 'Normal Seal'</title>
            <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Seal Treatment Performance- Subjective</title>
          <description>Seal performance 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 group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither good nor poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for all participants during the 2 month study period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Toffee Full Face Mask With 'Improved Seal'</title>
          <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.</description>
        </group>
        <group group_id="E2">
          <title>Toffee Full Face Mask With 'Normal Seal'</title>
          <description>Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.&#xD;
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.</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"/>
                <counts group_id="E2" 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"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </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>Sarah Gunson</name_or_title>
      <organization>Fisher &amp; Paykel Healthcare Ltd.</organization>
      <phone>+64 9 574 0123 ext 7675</phone>
      <email>sarah.gunson@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/NCT03230877
org study id: CIA-223
nct id: NCT03230877
lead sponsor: 
has dmc: Yes
is unapproved device: Yes
The investigation is a prospective, randomized, single blinded, crossover study. The
      investigation is designed to evaluate the performance, comfort and ease of use of the F&P
      Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number
      of 40-45 OSA participants will be recruited for the trial by the investigation site
This study will involve three visits to the investigation site. During visit one participants
      will be randomized to, fitted with and issued with the first trial mask seal for use in- home
      for 7 ±4 days.

      The participants will then come in to return the mask seal and be fitted and issued with the
      second trial seal for use in home for 7±4 days.

      Visit Three will involve the participants returning the second trial seal and providing
      feedback.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Trial Mask Seal Comfort
time frame: 7 ± 4 days in-home
description: Overall seal comfort determined from questionnaires- Subjective
measure: Trial Mask Seal Acceptability
time frame: 14 ± 4 days in-home
description: Preference for trial mask determined from questionnaires at the end of the trial - Subjective
measure: Trial Mask Seal Treatment Performance - Objective
time frame: 7 ± 4 days in-home
description: Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
measure: Trial Mask Seal Usability
time frame: 1 hour day-time appointment
description: Usability interview during first visit- Subjective
measure: Trial Mask Seal Treatment Performance- Subjective
time frame: 7 ± 4 days in-home
description: Seal performance determined from questionnaires - Subjective
arm group label: Group A
arm group type: Experimental
description: Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
arm group label: Group B
arm group type: Experimental
description: Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
intervention type: Device
intervention name: Toffee full face mask with 'Improved Seal'
description: Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
arm group label: Group A
arm group label: Group B
intervention type: Device
intervention name: Toffee full face mask with 'Normal Seal'
description: Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
arm group label: Group A
arm group label: Group B
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: This investigation is to inform product development team. Results will inform product development on the future of the product.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 