<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/NCT03294629</url>
  </required_header>
  <id_info>
    <org_study_id>103-7083B</org_study_id>
    <nct_id>NCT03294629</nct_id>
  </id_info>
  <brief_title>The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients</brief_title>
  <official_title>Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons During Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting&#xD;
      Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires&#xD;
      experimental confirmation in a randomised controlled trial with crossover design, comparing&#xD;
      compliance on standard APAP with compliance using APAP modified by the addition of the&#xD;
      SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance of Auto-CPAP Therapy</measure>
    <time_frame>2 weeks</time_frame>
    <description>Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average SA Detections</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pressures of Auto-CPAP Machine</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90th Percentile Pressures of Auto-CPAP Machine</measure>
    <time_frame>2 weeks</time_frame>
    <description>90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Leaks of Auto-CPAP Machine</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90th Percentile Leaks of Auto-CPAP Machine</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Apnea-Hypopnea Index (AHI)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Used of Auto-CPAP Machine</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Day Used of Auto-CPAP Machine</measure>
    <time_frame>2 weeks</time_frame>
    <description>Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Score (ESS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Obstruction Symptom Evaluation (NOSE)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>APAP begins without SensAwake</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>APAP begins with SensAwake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks.&#xD;
SensAwake™ modification: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SensAwake™ modification</intervention_name>
    <description>SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.</description>
    <arm_group_label>APAP begins with SensAwake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Participants will be recruited from OSA patients who will remove CPAP himself without&#xD;
        any notable reasons.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable cardiovascular disease (untreated or resistant hypertension acceptable).&#xD;
&#xD;
          2. Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by&#xD;
             the study investigator.&#xD;
&#xD;
          3. Any known factor or disease that might interfere with treatment compliance, study&#xD;
             conduct or interpretation of the results such as psychiatric disease, history of non&#xD;
             compliance to medical regimens, or unwillingness to comply with study requirements.&#xD;
&#xD;
          4. Any known factor that result in mask taken of such as skin discomfort, nasal&#xD;
             obstruction, water dripping inside the tubing system etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-Pang Chuang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ChangGungMemorialHospital</affiliation>
  </overall_official>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 5, 2015</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>March 12, 2018</results_first_submitted>
  <results_first_submitted_qc>May 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 12, 2018</results_first_posted>
  <last_update_submitted>May 11, 2018</last_update_submitted>
  <last_update_submitted_qc>May 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cPAP</keyword>
  <keyword>SenseAwake</keyword>
  <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>
      <recruitment_details>March 2015 to Mar 2016, at medical clinic.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>CPAP w/SensAwake First, Then CPAP w/o SensAwake</title>
          <description>Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period.</description>
        </group>
        <group group_id="P2">
          <title>CPAP w/o SensAwake First, Then CPAP w/SensAwake</title>
          <description>Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (2 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (2 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CPAP w/SensAwake First, Then CPAP w/o SensAwake</title>
          <description>Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period.</description>
        </group>
        <group group_id="B2">
          <title>CPAP w/o SensAwake First, Then CPAP w/SensAwake</title>
          <description>Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period.</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="12"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="47.6" spread="10.9"/>
                    <measurement group_id="B2" value="41.5" spread="12.0"/>
                    <measurement group_id="B3" value="44.0" spread="11.7"/>
                  </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="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" spread="4.3"/>
                    <measurement group_id="B2" value="32.9" spread="6.9"/>
                    <measurement group_id="B3" value="32.4" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Neck Circumference (NC)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.3" spread="2.1"/>
                    <measurement group_id="B2" value="41.0" spread="2.2"/>
                    <measurement group_id="B3" value="41.6" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Apnea-hypopnea index (AHI)</title>
          <description>Apnea-hypopnea index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep that recorded in polysomnography.</description>
          <units>events per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.3" spread="30.8"/>
                    <measurement group_id="B2" value="54.0" spread="35.3"/>
                    <measurement group_id="B3" value="54.6" spread="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sleep efficiency</title>
          <description>Sleep efficiency is presented by percentage of minutes of sleep divided by the minutes in bed.</description>
          <units>% (percentage of minutes slept)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.0" spread="8.9"/>
                    <measurement group_id="B2" value="73.0" spread="21.3"/>
                    <measurement group_id="B3" value="77.1" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total sleep time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="301.0" spread="34.2"/>
                    <measurement group_id="B2" value="276.2" spread="79.2"/>
                    <measurement group_id="B3" value="287.6" spread="62.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Deep sleep - Stage 3</title>
          <description>Deep sleep is presented by percentage of minutes of stage 3 divided by the minutes of all sleep time.</description>
          <units>% (percentage of minutes of stage 3)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.1" spread="10.4"/>
                    <measurement group_id="B2" value="4.4" spread="5.6"/>
                    <measurement group_id="B3" value="5.2" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average used time of CPAP</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="187.4" spread="104.6"/>
                    <measurement group_id="B2" value="227.9" spread="104.1"/>
                    <measurement group_id="B3" value="208.5" spread="104.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Compliance of CPAP</title>
          <description>CPAP compliance is defined as using the therapy for more than 4 hours a night of all the nights.</description>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.9" spread="31.9"/>
                    <measurement group_id="B2" value="46.2" spread="30.6"/>
                    <measurement group_id="B3" value="39.3" spread="31.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Residual AHI under CPAP Tx</title>
          <description>Apnea-hypopnea index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Residual AHI is recorded by CPAP device.</description>
          <units>events per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.9" spread="1.3"/>
                    <measurement group_id="B2" value="4.4" spread="2.8"/>
                    <measurement group_id="B3" value="3.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pittsburgh Sleep Quality Index (PSQI)</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.4" spread="2.3"/>
                    <measurement group_id="B2" value="10.1" spread="3.8"/>
                    <measurement group_id="B3" value="8.8" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Epworth Sleepiness Scale (ESS)</title>
          <description>The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.3" spread="5.5"/>
                    <measurement group_id="B2" value="13.1" spread="6.7"/>
                    <measurement group_id="B3" value="13.2" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nasal Obstruction Symptom Evaluation (NOSE)</title>
          <description>The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" spread="6.8"/>
                    <measurement group_id="B2" value="15.6" spread="8.4"/>
                    <measurement group_id="B3" value="14.6" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Compliance of Auto-CPAP Therapy</title>
        <description>Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance of Auto-CPAP Therapy</title>
          <description>Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.</description>
          <units>percentage of nights</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8" spread="35.0"/>
                    <measurement group_id="O2" value="39.7" spread="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average SA Detections</title>
        <description>Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Average SA Detections</title>
          <description>Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)</description>
          <units>times/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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.9"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pressures of Auto-CPAP Machine</title>
        <description>Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pressures of Auto-CPAP Machine</title>
          <description>Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)</description>
          <units>cmH2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="2.7"/>
                    <measurement group_id="O2" value="7.3" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>90th Percentile Pressures of Auto-CPAP Machine</title>
        <description>90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>90th Percentile Pressures of Auto-CPAP Machine</title>
          <description>90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
          <units>cmH2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.0"/>
                    <measurement group_id="O2" value="9.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Leaks of Auto-CPAP Machine</title>
        <description>Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Average Leaks of Auto-CPAP Machine</title>
          <description>Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
          <units>liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="20.1"/>
                    <measurement group_id="O2" value="44.6" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>90th Percentile Leaks of Auto-CPAP Machine</title>
        <description>Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>90th Percentile Leaks of Auto-CPAP Machine</title>
          <description>Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
          <units>liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.6" spread="24.7"/>
                    <measurement group_id="O2" value="58.9" spread="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Residual Apnea-Hypopnea Index (AHI)</title>
        <description>Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Apnea-Hypopnea Index (AHI)</title>
          <description>Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.</description>
          <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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="6.7"/>
                    <measurement group_id="O2" value="5.0" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Used of Auto-CPAP Machine</title>
        <description>Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Time Used of Auto-CPAP Machine</title>
          <description>Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
          <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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213.1" spread="99.4"/>
                    <measurement group_id="O2" value="206.8" spread="87.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Day Used of Auto-CPAP Machine</title>
        <description>Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Day Used of Auto-CPAP Machine</title>
          <description>Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)</description>
          <units>Percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1" spread="13.8"/>
                    <measurement group_id="O2" value="88.1" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pittsburgh Sleep Quality Index (PSQI)</title>
        <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Pittsburgh Sleep Quality Index (PSQI)</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="2.6"/>
                    <measurement group_id="O2" value="8.0" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Epworth Sleepiness Score (ESS)</title>
        <description>The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Epworth Sleepiness Score (ESS)</title>
          <description>The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" spread="6.1"/>
                    <measurement group_id="O2" value="12.1" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Obstruction Symptom Evaluation (NOSE)</title>
        <description>The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SA ON</title>
            <description>CPAP with SensAwake activation</description>
          </group>
          <group group_id="O2">
            <title>SA OFF</title>
            <description>CPAP without SensAwake activation</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Obstruction Symptom Evaluation (NOSE)</title>
          <description>The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="8.1"/>
                    <measurement group_id="O2" value="13.3" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SA ON</title>
          <description>CPAP with SensAwake activation</description>
        </group>
        <group group_id="E2">
          <title>SA OFF</title>
          <description>CPAP without SensAwake activation</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </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>
      <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>Ning-Hung, Chen</name_or_title>
      <organization>Sleep Center, Taoyuan Chang Gung Memorial Hospital</organization>
      <phone>+886-3-3281200 ext 2281</phone>
      <email>ninghung@yahoo.com.tw</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/NCT03294629
org study id: 103-7083B
nct id: NCT03294629
lead sponsor: 
collaborator: 
has dmc: Yes
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting
      Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires
      experimental confirmation in a randomised controlled trial with crossover design, comparing
      compliance on standard APAP with compliance using APAP modified by the addition of the
      SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Compliance of Auto-CPAP Therapy
time frame: 2 weeks
description: Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
measure: Average SA Detections
time frame: 2 weeks
description: Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
measure: Average Pressures of Auto-CPAP Machine
time frame: 2 weeks
description: Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
measure: 90th Percentile Pressures of Auto-CPAP Machine
time frame: 2 weeks
description: 90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
measure: Average Leaks of Auto-CPAP Machine
time frame: 2 weeks
description: Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
measure: 90th Percentile Leaks of Auto-CPAP Machine
time frame: 2 weeks
description: Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
measure: Residual Apnea-Hypopnea Index (AHI)
time frame: 2 weeks
description: Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.
measure: Time Used of Auto-CPAP Machine
time frame: 2 weeks
description: Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
measure: Percentage of Day Used of Auto-CPAP Machine
time frame: 2 weeks
description: Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: 2 weeks
description: The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.
measure: Epworth Sleepiness Score (ESS)
time frame: 2 weeks
description: The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.
measure: Nasal Obstruction Symptom Evaluation (NOSE)
time frame: 2 weeks
description: The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.
arm group label: APAP begins without SensAwake
arm group type: No Intervention
description: Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.
arm group label: APAP begins with SensAwake
arm group type: Experimental
description: Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks.
SensAwake™ modification: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.
intervention type: Device
intervention name: SensAwake™ modification
description: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.
arm group label: APAP begins with SensAwake
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Li-Pang Chuang, MD
role: Principal Investigator
affiliation: ChangGungMemorialHospital
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: 