<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/NCT01690923</url>
  </required_header>
  <id_info>
    <org_study_id>MA000-1442</org_study_id>
    <nct_id>NCT01690923</nct_id>
  </id_info>
  <brief_title>Nasal Pillows vs. Nasal Masks at High CPAP Pressure</brief_title>
  <official_title>Nasal Pillows at High CPAP Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this evaluation is to test:&#xD;
&#xD;
        1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks&#xD;
&#xD;
        2. Patient mask type preferences at high pressures&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AHI on Nasal Mask and Pillows Mask</measure>
    <time_frame>7 days</time_frame>
    <description>AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability</measure>
    <time_frame>After 7 days of use</time_frame>
    <description>Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>OSA</condition>
  <arm_group>
    <arm_group_label>Nasal Mask First, then Pillows Mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights.&#xD;
[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pillows Mask, then Nasal Mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. [Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX]</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal mask</intervention_name>
    <description>Nasal mask (Mirage Activa, Micro, FX)</description>
    <arm_group_label>Nasal Mask First, then Pillows Mask</arm_group_label>
    <arm_group_label>Pillows Mask, then Nasal Mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pillows mask</intervention_name>
    <description>Nasal pillows mask (Swift FX)</description>
    <arm_group_label>Nasal Mask First, then Pillows Mask</arm_group_label>
    <arm_group_label>Pillows Mask, then Nasal Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients willing to give written informed consent&#xD;
&#xD;
          -  Patients who can read and comprehend English&#xD;
&#xD;
          -  Patients being treated for OSA for &gt;6 months&#xD;
&#xD;
          -  Patients ≥ 18 years of age&#xD;
&#xD;
          -  Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O&#xD;
&#xD;
          -  Patients who can trial the trial masks up to 14 nights&#xD;
&#xD;
          -  Patients naive to pillows mask systems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients using an inappropriate mask system&#xD;
&#xD;
          -  Patients using Bilevel flow generators&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Patients who have a pre-existing lung disease/ condition that would predispose them to&#xD;
             pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (&lt; 2years)&#xD;
             case of pneumonia or lung infection; lung injury)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Schindhelm, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>ResMed</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ResMed</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2153</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>September 26, 2014</results_first_submitted>
  <results_first_submitted_qc>October 7, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 8, 2014</results_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants recruited from ResMed Science Centre, Sydney, between Aug 2011 and Aug 2012</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Nasal Mask First, Then Pillows Mask</title>
          <description>Sequence 1: Nasal mask first, then Pillows mask&#xD;
[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]</description>
        </group>
        <group group_id="P2">
          <title>Pillows Mask First, Then Nasal Mask</title>
          <description>Sequence 2: Pillows mask first, then Nasal mask&#xD;
[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11">1 participant was withdrawn and excluded due to poor fit with the pillows mask</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Current CPAP Users</title>
          <description>Nasal mask; Pillows mask&#xD;
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)&#xD;
Pillows mask : Nasal pillows mask (Swift FX)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.6" spread="9.5"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Usability</title>
        <description>Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)</description>
        <time_frame>After 7 days of use</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Current CPAP Users</title>
            <description>Nasal mask; Pillows mask&#xD;
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)&#xD;
Pillows mask : Nasal pillows mask (Swift FX)</description>
          </group>
        </group_list>
        <measure>
          <title>Usability</title>
          <description>Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)</description>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <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>Subjective Scores Overall Performance-Nasal Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="7.25" upper_limit="9.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective Scores Overall Performance-Nasal Pillow</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="7" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AHI on Nasal Mask and Pillows Mask</title>
        <description>AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Current CPAP Users</title>
            <description>Nasal mask; Pillows mask&#xD;
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)&#xD;
Pillows mask : Nasal pillows mask (Swift FX)</description>
          </group>
        </group_list>
        <measure>
          <title>AHI on Nasal Mask and Pillows Mask</title>
          <description>AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour</description>
          <units>events/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <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>AHI on nasal mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AHI on Nasal pillows</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <desc>Adverse events were collected for the study participation period of 14 days. Adverse events were collected/ assessed through clinical interview. No adverse events were reported or observed during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Current CPAP Users</title>
          <description>Nasal mask; Pillows mask&#xD;
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)&#xD;
Pillows mask : Nasal pillows mask (Swift FX)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
              </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>
    <limitations_and_caveats>This study only included established CPAP users.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Xueling Zhu, Clinical Consultant</name_or_title>
      <organization>ResMed Ltd</organization>
      <phone>61288842265</phone>
      <email>xueling.zhu@resmed.com.au</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/NCT01690923
org study id: MA000-1442
nct id: NCT01690923
lead sponsor: 
has dmc: Yes
The aim of this evaluation is to test:

        1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks

        2. Patient mask type preferences at high pressures
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AHI on Nasal Mask and Pillows Mask
time frame: 7 days
description: AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
measure: Usability
time frame: After 7 days of use
description: Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)
arm group label: Nasal Mask First, then Pillows Mask
arm group type: Experimental
description: Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights.
[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX]
arm group label: Pillows Mask, then Nasal Mask
arm group type: Experimental
description: Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. [Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX]
intervention type: Device
intervention name: Nasal mask
description: Nasal mask (Mirage Activa, Micro, FX)
arm group label: Nasal Mask First, then Pillows Mask
arm group label: Pillows Mask, then Nasal Mask
intervention type: Device
intervention name: Pillows mask
description: Nasal pillows mask (Swift FX)
arm group label: Nasal Mask First, then Pillows Mask
arm group label: Pillows Mask, then Nasal Mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Klaus Schindhelm, Prof
role: Principal Investigator
affiliation: ResMed
facility: 
country: Australia
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study only included established CPAP users.
point of contact: 