<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/NCT02214238</url>
  </required_header>
  <id_info>
    <org_study_id>CIA-116</org_study_id>
    <nct_id>NCT02214238</nct_id>
  </id_info>
  <brief_title>Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.</brief_title>
  <official_title>Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea, in Comparison to a Market Released Device.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fisher and Paykel Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the hypothesis that the modified positive airway pressure (PAP) device&#xD;
      for OSA will be no worse than a market released product in terms of its treatment efficacy,&#xD;
      comfort and patient compliance. Patients will have their treatment pressure titrated using&#xD;
      polysomnography (PSG) in the sleep laboratory, and then in a random order will spend&#xD;
      additional time undergoing PSG using both devices, and using both devices at home for 3&#xD;
      weeks. Data will be collected from the PSG studies, device downloads, independent&#xD;
      pressure-flow loggers, and custom questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be held in two parts. The main portion of the study which compares the&#xD;
      modified PAP device and the market released product including the laboratory testing and home&#xD;
      testing of the devices will be called 'Part A'. Additional nights using the PAP device with&#xD;
      PSG monitoring will be used to gather additional observational flow data to allow distortion&#xD;
      testing and investigation of the FPH (Fisher &amp; Paykel Healthcare) SensAwake (an unique&#xD;
      feature which automatically lowers the pressure when a patient wakes up) algorithm while&#xD;
      using PAP, this is part B.&#xD;
&#xD;
      Part A After the patient has undergone informed consent, their demographic and clinical&#xD;
      variables will be collected and entered into a case report form (CRF) before any setup&#xD;
      procedure is started. The patient will be asked to complete questionnaires regarding their&#xD;
      normal therapy (ESS (Epworth Sleepiness Score), FOSQ (Functional Outcomes of Sleep&#xD;
      Questionnaire), custom therapy comfort questionnaire), and then will be set up for a standard&#xD;
      PSG. The patient will use their prescribed mask and a clean water chamber and breathing tube&#xD;
      which will be connected to the modified PAP device. The patients will sleep on the device&#xD;
      throughout the night while having their PAP titrated by a qualified sleep technician.&#xD;
      Pressure titration is necessary for two reasons: firstly, it may have been a period of time&#xD;
      since the participants last titration, and secondly this version of PAP involves the use of&#xD;
      different levels of pressure. Pressures will be titrated according to the AASM (American&#xD;
      Academy of Sleep Medicine) Clinical Guidelines for the Manual Titration of Positive Airway&#xD;
      Pressure in Patients with OSA.&#xD;
&#xD;
      The participant will be randomized to either the modified PAP or market released device&#xD;
      group. They will be issued with a PAP device and a pressure-flow logger to be used at home in&#xD;
      the usual manner of their PAP therapy for 3 weeks (+/- 4 days), after which participants will&#xD;
      return to the FPH sleep laboratory to participate in a overnight PSG study using their first&#xD;
      device. At this visit the participant will also swap to the second PAP device; and the above&#xD;
      home use repeated on device 2.&#xD;
&#xD;
      Part B After informed consent form the patient will be set up for a standard PSG, and sleep&#xD;
      overnight using the modified PAP device, their prescribed mask, and a clean water chamber and&#xD;
      breathing tube. This testing will be performed to provide additional flow data to the&#xD;
      development engineers. This includes, but is not limited to, distortion testing and&#xD;
      adjustment of device parameters during the sleep study. Distortion testing analyses the&#xD;
      impact of the PAP pressure changes on the participants breathing or airflow.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>PAP Treatment Efficacy</measure>
    <time_frame>After 1 night in the sleep lab and 3 weeks use of the device in the home.</time_frame>
    <description>The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PAP Treatment Comfort</measure>
    <time_frame>After 1 night in the sleep lab and 3 weeks use of the device in the home.</time_frame>
    <description>Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAP Compliance</measure>
    <time_frame>After 1 night in the sleep lab and 3 weeks use of the device in the home.</time_frame>
    <description>Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Obstructive Sleep Apnea (OSA)</condition>
  <arm_group>
    <arm_group_label>Market released PAP device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of a market released PAP device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified PAP device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Us of the modified PAP device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PAP device</intervention_name>
    <arm_group_label>Market released PAP device</arm_group_label>
    <arm_group_label>Modified PAP device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18+&#xD;
&#xD;
          -  Diagnosed with OSA by a practicing sleep physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known history of Cerebrospinal fluid leak, abnormalities of the&#xD;
             cribriform plate, head trauma and/or pneumocephalus&#xD;
&#xD;
          -  Patients with pathologically low blood pressure, pneumothorax, a previous history of&#xD;
             pneumothorax, or dehydration.&#xD;
&#xD;
          -  Patient with bypassed upper airway&#xD;
&#xD;
          -  Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central&#xD;
             sleep apnea)&#xD;
&#xD;
          -  Previous use of a bi-level device with-in the last 2 years (from enrolment date).&#xD;
&#xD;
          -  Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive&#xD;
             Pulmonary Disease).&#xD;
&#xD;
          -  Patients with obesity hypoventilation syndrome or congestive heart failure&#xD;
&#xD;
          -  Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway&#xD;
             Pressure) device&#xD;
&#xD;
          -  Patients with implanted or life-supporting electronic medical devices (e.g. cardiac&#xD;
             pacemakers)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanie Yee</last_name>
    <role>Study Director</role>
    <affiliation>Fisher &amp; Paykel Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fisher &amp; Paykel Healthcare</name>
      <address>
        <city>Auckland</city>
        <zip>2013</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>October 11, 2016</results_first_submitted>
  <results_first_submitted_qc>March 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2017</results_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Market Released PAP Device First, Then Modified PAP Device</title>
          <description>Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.</description>
        </group>
        <group group_id="P2">
          <title>Modified PAP Device First, Then Market Released PAP Device</title>
          <description>Use of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Market Released PAP Device First, Then Modified PAP Device</title>
          <description>Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.</description>
        </group>
        <group group_id="B2">
          <title>Modified PAP Device First, Then Market Released PAP Device</title>
          <description>Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.2" lower_limit="48" upper_limit="81"/>
                    <measurement group_id="B2" value="58.7" lower_limit="32" upper_limit="81"/>
                    <measurement group_id="B3" value="60.9" lower_limit="32" upper_limit="81"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </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>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PAP Treatment Efficacy</title>
        <description>The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.</description>
        <time_frame>After 1 night in the sleep lab and 3 weeks use of the device in the home.</time_frame>
        <population>The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.</population>
        <group_list>
          <group group_id="O1">
            <title>Market Released PAP Device</title>
            <description>Use of a market released PAP device&#xD;
PAP device</description>
          </group>
          <group group_id="O2">
            <title>Modified PAP Device</title>
            <description>Use of the modified PAP device&#xD;
PAP device</description>
          </group>
        </group_list>
        <measure>
          <title>PAP Treatment Efficacy</title>
          <description>The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.</description>
          <population>The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.</population>
          <units>Events per 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="37"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.0"/>
                    <measurement group_id="O2" value="4.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PAP Treatment Comfort</title>
        <description>Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.</description>
        <time_frame>After 1 night in the sleep lab and 3 weeks use of the device in the home.</time_frame>
        <population>The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.</population>
        <group_list>
          <group group_id="O1">
            <title>Market Released PAP Device</title>
            <description>Use of a market released PAP device&#xD;
PAP device</description>
          </group>
          <group group_id="O2">
            <title>Modified PAP Device</title>
            <description>Use of the modified PAP device&#xD;
PAP device</description>
          </group>
        </group_list>
        <measure>
          <title>PAP Treatment Comfort</title>
          <description>Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.</description>
          <population>The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.</population>
          <units>Units on a Scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="5" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PAP Compliance</title>
        <description>Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.</description>
        <time_frame>After 1 night in the sleep lab and 3 weeks use of the device in the home.</time_frame>
        <population>The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.</population>
        <group_list>
          <group group_id="O1">
            <title>Market Released PAP Device</title>
            <description>Use of a market released PAP device&#xD;
PAP device</description>
          </group>
          <group group_id="O2">
            <title>Modified PAP Device</title>
            <description>Use of the modified PAP device&#xD;
PAP device</description>
          </group>
        </group_list>
        <measure>
          <title>PAP Compliance</title>
          <description>Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.</description>
          <population>The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="438" spread="13"/>
                    <measurement group_id="O2" value="430" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Modified PAP Device</title>
          <description>Use of a modified PAP device for 3 more weeks.</description>
        </group>
        <group group_id="E2">
          <title>Market Released PAP Device</title>
          <description>Use of a market released PAP device for 3 more weeks.</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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="5" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ectopic Beats</sub_title>
                <description>Observed during PSG</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Snoring and somnolence</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nose bleed</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>Determined by hospital physicians to be related to patients Blood Pressure medications</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>High AHI on PSG</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cricopharyngeal Spasm</sub_title>
                <description>Sensation of lump in the throat</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Shoulder Operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </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>Clinical Research Scientist</name_or_title>
      <organization>Fisher &amp; Paykel Healthcare</organization>
      <phone>+6495740123</phone>
      <email>cpaptrial@fphcare.co.nz</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02214238
org study id: CIA-116
nct id: NCT02214238
lead sponsor: 
has dmc: No
This study will test the hypothesis that the modified positive airway pressure (PAP) device
      for OSA will be no worse than a market released product in terms of its treatment efficacy,
      comfort and patient compliance. Patients will have their treatment pressure titrated using
      polysomnography (PSG) in the sleep laboratory, and then in a random order will spend
      additional time undergoing PSG using both devices, and using both devices at home for 3
      weeks. Data will be collected from the PSG studies, device downloads, independent
      pressure-flow loggers, and custom questionnaires.
The study will be held in two parts. The main portion of the study which compares the
      modified PAP device and the market released product including the laboratory testing and home
      testing of the devices will be called 'Part A'. Additional nights using the PAP device with
      PSG monitoring will be used to gather additional observational flow data to allow distortion
      testing and investigation of the FPH (Fisher & Paykel Healthcare) SensAwake (an unique
      feature which automatically lowers the pressure when a patient wakes up) algorithm while
      using PAP, this is part B.

      Part A After the patient has undergone informed consent, their demographic and clinical
      variables will be collected and entered into a case report form (CRF) before any setup
      procedure is started. The patient will be asked to complete questionnaires regarding their
      normal therapy (ESS (Epworth Sleepiness Score), FOSQ (Functional Outcomes of Sleep
      Questionnaire), custom therapy comfort questionnaire), and then will be set up for a standard
      PSG. The patient will use their prescribed mask and a clean water chamber and breathing tube
      which will be connected to the modified PAP device. The patients will sleep on the device
      throughout the night while having their PAP titrated by a qualified sleep technician.
      Pressure titration is necessary for two reasons: firstly, it may have been a period of time
      since the participants last titration, and secondly this version of PAP involves the use of
      different levels of pressure. Pressures will be titrated according to the AASM (American
      Academy of Sleep Medicine) Clinical Guidelines for the Manual Titration of Positive Airway
      Pressure in Patients with OSA.

      The participant will be randomized to either the modified PAP or market released device
      group. They will be issued with a PAP device and a pressure-flow logger to be used at home in
      the usual manner of their PAP therapy for 3 weeks (+/- 4 days), after which participants will
      return to the FPH sleep laboratory to participate in a overnight PSG study using their first
      device. At this visit the participant will also swap to the second PAP device; and the above
      home use repeated on device 2.

      Part B After informed consent form the patient will be set up for a standard PSG, and sleep
      overnight using the modified PAP device, their prescribed mask, and a clean water chamber and
      breathing tube. This testing will be performed to provide additional flow data to the
      development engineers. This includes, but is not limited to, distortion testing and
      adjustment of device parameters during the sleep study. Distortion testing analyses the
      impact of the PAP pressure changes on the participants breathing or airflow.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PAP Treatment Efficacy
time frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
description: The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.
measure: PAP Treatment Comfort
time frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
description: Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.
measure: PAP Compliance
time frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
description: Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.
arm group label: Market released PAP device
arm group type: Active Comparator
description: Use of a market released PAP device
arm group label: Modified PAP device
arm group type: Experimental
description: Us of the modified PAP device
intervention type: Device
intervention name: PAP device
arm group label: Market released PAP device
arm group label: Modified PAP device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Hanie Yee
role: Study Director
affiliation: Fisher & Paykel Healthcare
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 