<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/NCT02971436</url>
  </required_header>
  <id_info>
    <org_study_id>CIA196</org_study_id>
    <nct_id>NCT02971436</nct_id>
  </id_info>
  <brief_title>Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fisher and Paykel Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)&#xD;
      device with or without SensAwake; and with different pressure support in OSA participants; in&#xD;
      both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure&#xD;
      delivery will also be evaluated. The FPH device will be compared to a market released&#xD;
      product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    project progression decision was able to be made with the data already gathered&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea Hypopnea Index (AHI)</measure>
    <time_frame>3 nights</time_frame>
    <description>Through the device and independent flow logger</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apnea Hypopnea Index (AHI)</measure>
    <time_frame>1 night</time_frame>
    <description>Through the polysomnography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapy Comfort</measure>
    <time_frame>3 nights</time_frame>
    <description>Through a subjective questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>3 nights</time_frame>
    <description>Through the device and independent flow logger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Triggering</measure>
    <time_frame>3 nights</time_frame>
    <description>Through the device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Triggering</measure>
    <time_frame>1 night</time_frame>
    <description>Through the polysomnography</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>FPH Device with SensAwake On + Pressure Support A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FPH Device with SensAwake On + Pressure Support A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FPH Device with SensAwake Off + Pressure Support A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FPH Device with SensAwake Off + Pressure Support A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FPH Device with SensAwake On + Pressure Support B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FPH Device with SensAwake On + Pressure Support B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FPH Device with SensAwake Off + Pressure Support B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FPH Device with SensAwake Off + Pressure Support B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Competitor's PAP Released Device + Pressure Support A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Competitor's PAP Released Device + Pressure Support A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Competitor's PAP Released Device + Pressure Support B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Competitor's PAP Released Device + Pressure Support B</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FPH Device with SensAwake On + Pressure Support A</intervention_name>
    <description>FPH Device with SensAwake On + Pressure Support A</description>
    <arm_group_label>FPH Device with SensAwake On + Pressure Support A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FPH Device with SensAwake Off + Pressure Support A</intervention_name>
    <description>FPH Device with SensAwake Off + Pressure Support A</description>
    <arm_group_label>FPH Device with SensAwake Off + Pressure Support A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FPH Device with SensAwake On + Pressure Support B</intervention_name>
    <description>FPH Device with SensAwake On + Pressure Support B</description>
    <arm_group_label>FPH Device with SensAwake On + Pressure Support B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FPH Device with SensAwake Off + Pressure Support B</intervention_name>
    <description>FPH Device with SensAwake Off + Pressure Support B</description>
    <arm_group_label>FPH Device with SensAwake Off + Pressure Support B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Competitor's PAP Released Device + Pressure Support A</intervention_name>
    <description>Competitor's PAP Released Device + Pressure Support A</description>
    <arm_group_label>Competitor's PAP Released Device + Pressure Support A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Competitor's PAP Released Device + Pressure Support B</intervention_name>
    <description>Competitor's PAP Released Device + Pressure Support B</description>
    <arm_group_label>Competitor's PAP Released Device + Pressure Support B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 and over&#xD;
&#xD;
          -  Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure&#xD;
             (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be&#xD;
             naïve to CPAP or experienced users of CPAP.&#xD;
&#xD;
          -  For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4&#xD;
             hours/night for 70% during the last 30 days (justification allowed by the&#xD;
             investigator)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for PAP (CPAP or AutoCPAP) therapy&#xD;
&#xD;
          -  Persons with other significant sleep disorder(s) (e.g periodic leg movements,&#xD;
             insomnia, central sleep apnea)&#xD;
&#xD;
          -  Persons with obesity hypoventilation syndrome or congestive heart failure.&#xD;
&#xD;
          -  Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device&#xD;
&#xD;
          -  Persons with implanted electronic medical device (e.g cardiac pacemakers)&#xD;
&#xD;
          -  Persons who are pregnant or think they might be pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fisher &amp; Paykel Healthcare</name>
      <address>
        <city>Auckland</city>
        <zip>0600</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSleep Centre</name>
      <address>
        <city>Wellington</city>
        <zip>6035</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</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>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02971436
org study id: CIA196
nct id: NCT02971436
lead sponsor: 
has dmc: Yes
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)
      device with or without SensAwake; and with different pressure support in OSA participants; in
      both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure
      delivery will also be evaluated. The FPH device will be compared to a market released
      product.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Apnea Hypopnea Index (AHI)
time frame: 3 nights
description: Through the device and independent flow logger
measure: Apnea Hypopnea Index (AHI)
time frame: 1 night
description: Through the polysomnography
measure: Therapy Comfort
time frame: 3 nights
description: Through a subjective questionnaire
measure: Compliance
time frame: 3 nights
description: Through the device and independent flow logger
measure: Device Triggering
time frame: 3 nights
description: Through the device
measure: Device Triggering
time frame: 1 night
description: Through the polysomnography
arm group label: FPH Device with SensAwake On + Pressure Support A
arm group type: Active Comparator
description: FPH Device with SensAwake On + Pressure Support A
arm group label: FPH Device with SensAwake Off + Pressure Support A
arm group type: Active Comparator
description: FPH Device with SensAwake Off + Pressure Support A
arm group label: FPH Device with SensAwake On + Pressure Support B
arm group type: Active Comparator
description: FPH Device with SensAwake On + Pressure Support B
arm group label: FPH Device with SensAwake Off + Pressure Support B
arm group type: Active Comparator
description: FPH Device with SensAwake Off + Pressure Support B
arm group label: Competitor's PAP Released Device + Pressure Support A
arm group type: Active Comparator
description: Competitor's PAP Released Device + Pressure Support A
arm group label: Competitor's PAP Released Device + Pressure Support B
arm group type: Active Comparator
description: Competitor's PAP Released Device + Pressure Support B
intervention type: Device
intervention name: FPH Device with SensAwake On + Pressure Support A
description: FPH Device with SensAwake On + Pressure Support A
arm group label: FPH Device with SensAwake On + Pressure Support A
intervention type: Device
intervention name: FPH Device with SensAwake Off + Pressure Support A
description: FPH Device with SensAwake Off + Pressure Support A
arm group label: FPH Device with SensAwake Off + Pressure Support A
intervention type: Device
intervention name: FPH Device with SensAwake On + Pressure Support B
description: FPH Device with SensAwake On + Pressure Support B
arm group label: FPH Device with SensAwake On + Pressure Support B
intervention type: Device
intervention name: FPH Device with SensAwake Off + Pressure Support B
description: FPH Device with SensAwake Off + Pressure Support B
arm group label: FPH Device with SensAwake Off + Pressure Support B
intervention type: Device
intervention name: Competitor's PAP Released Device + Pressure Support A
description: Competitor's PAP Released Device + Pressure Support A
arm group label: Competitor's PAP Released Device + Pressure Support A
intervention type: Device
intervention name: Competitor's PAP Released Device + Pressure Support B
description: Competitor's PAP Released Device + Pressure Support B
arm group label: Competitor's PAP Released Device + Pressure Support B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive