<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/NCT03242148</url>
  </required_header>
  <id_info>
    <org_study_id>CIA 219</org_study_id>
    <nct_id>NCT03242148</nct_id>
  </id_info>
  <brief_title>The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea</brief_title>
  <official_title>The Evaluation of the Toffee Nasal Pillows 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>
    <collaborator>
      <agency>Aspen Clinical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation is a prospective, non-randomized, non-blinded study. This investigation is&#xD;
      designed to evaluate the performance, comfort and ease of use of the F&amp;P Toffee nasal pillows&#xD;
      mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited&#xD;
      from the Ohio Sleep Medical Institute (OSMI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1 will involve the participants being consented into the trial. Visit 2 will involve&#xD;
      the participants being fitted with the F&amp;P Toffee nasal pillows mask for use in-home.&#xD;
&#xD;
      The participant will then come in to return the mask (Visit Three) and have a final&#xD;
      interview, this ensures the maximum time participants will be exposed to the Toffee mask in&#xD;
      home will be 14 ± 4 days from visit two.&#xD;
&#xD;
      The mask will be returned to the Institution at the conclusion of the trial and the&#xD;
      participant will return to their previous mask. The Institution will recruit all patients&#xD;
      within 1 week of the beginning of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2017</start_date>
  <completion_date type="Actual">November 3, 2017</completion_date>
  <primary_completion_date type="Actual">November 3, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Toffee Mask Usability</measure>
    <time_frame>14 ± 5 days in-Home</time_frame>
    <description>Questionnaire on usability during second visit - Subjective.&#xD;
Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toffee Mask Comfort</measure>
    <time_frame>14 ± 5 days in-Home</time_frame>
    <description>Determine from questionnaires - Subjective&#xD;
Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toffee Mask Treatment Performance - Subjective</measure>
    <time_frame>14 ± 5 days in-Home</time_frame>
    <description>Determined from questionnaires - Subjective&#xD;
Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial Mask Acceptability</measure>
    <time_frame>14 ± 5 days in-Home</time_frame>
    <description>Participant count regarding whether they would continue using the trial mask if given the choice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toffee Mask Treatment Performance - Objective</measure>
    <time_frame>14 ± 5 days in-Home</time_frame>
    <description>Objective data recorded from PAP device - Objective&#xD;
Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a &quot;pass&quot; or &quot;fail&quot; based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.</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>Toffee Nasal Pillows 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 2. participants will be using the Toffee mask during this treatment arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Toffee Nasal Pillows Mask</intervention_name>
    <description>Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</description>
    <arm_group_label>Toffee Nasal Pillows Mask</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 nasal pillows 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>
  <overall_official>
    <last_name>Asim Roy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Board Certified Sleep Specialist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio Sleep Medicine Institute</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>April 5, 2021</results_first_submitted>
  <results_first_submitted_qc>May 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2021</results_first_posted>
  <disposition_first_submitted>March 19, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>May 27, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 1, 2021</disposition_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</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>
  <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 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03242148/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Toffee Nasal Pillows Mask</title>
          <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</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>Toffee Nasal Pillows Mask</title>
          <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment 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, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>22-35</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36-45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>46-55</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>56-65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>66-75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>76-85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </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>Toffee Mask Usability</title>
        <description>Questionnaire on usability during second visit - Subjective.&#xD;
Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.</description>
        <time_frame>14 ± 5 days in-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Nasal Pillows Mask</title>
            <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Toffee Mask Usability</title>
          <description>Questionnaire on usability during second visit - Subjective.&#xD;
Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.</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>
              <category_list>
                <category>
                  <title>Rating Very easy or easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rating very difficult or difficult</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rating Neither</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Toffee Mask Comfort</title>
        <description>Determine from questionnaires - Subjective&#xD;
Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor</description>
        <time_frame>14 ± 5 days in-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Nasal Pillows Mask</title>
            <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Toffee Mask Comfort</title>
          <description>Determine from questionnaires - Subjective&#xD;
Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor</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>
              <category_list>
                <category>
                  <title>Rated very good or good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very poor, poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Toffee Mask Treatment Performance - Subjective</title>
        <description>Determined from questionnaires - Subjective&#xD;
Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor</description>
        <time_frame>14 ± 5 days in-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Nasal Pillows Mask</title>
            <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Toffee Mask Treatment Performance - Subjective</title>
          <description>Determined from questionnaires - Subjective&#xD;
Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor</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>
              <category_list>
                <category>
                  <title>Rated very good or good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rated poor or very poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rated neither</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trial Mask Acceptability</title>
        <description>Participant count regarding whether they would continue using the trial mask if given the choice.</description>
        <time_frame>14 ± 5 days in-Home</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Toffee Nasal Pillows Mask</title>
            <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trial Mask Acceptability</title>
          <description>Participant count regarding whether they would continue using the trial mask if given the choice.</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="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Toffee Mask Treatment Performance - Objective</title>
        <description>Objective data recorded from PAP device - Objective&#xD;
Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a &quot;pass&quot; or &quot;fail&quot; based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.</description>
        <time_frame>14 ± 5 days in-Home</time_frame>
        <population>4 data sets were unavailable for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Toffee Nasal Pillows Mask</title>
            <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Toffee Mask Treatment Performance - Objective</title>
          <description>Objective data recorded from PAP device - Objective&#xD;
Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a &quot;pass&quot; or &quot;fail&quot; based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.</description>
          <population>4 data sets were unavailable for analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pass</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fail</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for all participants for 1 year from the date informed consent was obtained.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Toffee Nasal Pillows Mask</title>
          <description>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm&#xD;
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during 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"/>
              </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>0</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="8" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Irritation</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sore on the top of the head</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" 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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research Scientist</name_or_title>
      <organization>Fisher and Paykel Healthcare</organization>
      <phone>+64 09 574 0123 ext 7044</phone>
      <email>CPAP.trial@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/NCT03242148
org study id: CIA 219
nct id: NCT03242148
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This investigation is a prospective, non-randomized, non-blinded study. This investigation is
      designed to evaluate the performance, comfort and ease of use of the F&P Toffee nasal pillows
      mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited
      from the Ohio Sleep Medical Institute (OSMI)
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve
      the participants being fitted with the F&P Toffee nasal pillows mask for use in-home.

      The participant will then come in to return the mask (Visit Three) and have a final
      interview, this ensures the maximum time participants will be exposed to the Toffee mask in
      home will be 14 ± 4 days from visit two.

      The mask will be returned to the Institution at the conclusion of the trial and the
      participant will return to their previous mask. The Institution will recruit all patients
      within 1 week of the beginning of the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toffee Mask Usability
time frame: 14 ± 5 days in-Home
description: Questionnaire on usability during second visit - Subjective.
Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.
measure: Toffee Mask Comfort
time frame: 14 ± 5 days in-Home
description: Determine from questionnaires - Subjective
Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor
measure: Toffee Mask Treatment Performance - Subjective
time frame: 14 ± 5 days in-Home
description: Determined from questionnaires - Subjective
Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor
measure: Trial Mask Acceptability
time frame: 14 ± 5 days in-Home
description: Participant count regarding whether they would continue using the trial mask if given the choice.
measure: Toffee Mask Treatment Performance - Objective
time frame: 14 ± 5 days in-Home
description: Objective data recorded from PAP device - Objective
Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a "pass" or "fail" based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.
arm group label: Toffee Nasal Pillows Mask
arm group type: Experimental
description: Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
intervention type: Device
intervention name: Toffee Nasal Pillows Mask
description: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
arm group label: Toffee Nasal Pillows Mask
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Asim Roy
role: Principal Investigator
affiliation: Board Certified Sleep Specialist
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 