<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/NCT01679301</url>
  </required_header>
  <id_info>
    <org_study_id>HRC-1216-SimGoSleep-SS</org_study_id>
    <nct_id>NCT01679301</nct_id>
  </id_info>
  <brief_title>Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator</brief_title>
  <official_title>Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Respironics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Respironics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30&#xD;
      participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen,&#xD;
      and meeting all eligibility criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will undergo a single night polysomnography testing in a sleep lab while&#xD;
      they're oxygen saturation (SpO2) is monitored. The study has a cross-over design, in which&#xD;
      participants will receive their oxygen prescription in two different modes at different times&#xD;
      during the night. The assignment (sleep vs. continuous mode) to which participants will&#xD;
      initiate the night will be randomized, and all participants will utilize each of the two&#xD;
      modes during the study. The hypothesis of this study is that there will not be a significant&#xD;
      difference in SpO2 for participants while they use the SimplyGo Portable Oxygen Concentrator,&#xD;
      set in 'Sleep Mode', or pulsed oxygen flow, as compared to their SpO2 while on continuous&#xD;
      flow oxygen during sleep during the course of the one night sleep study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen Saturation Values Obtained From Pulse Oximetry</measure>
    <time_frame>Day 1</time_frame>
    <description>A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Lung Disease</condition>
  <arm_group>
    <arm_group_label>Continuous dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulse dose ('sleep mode')</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse Dose (Sleep Mode)</intervention_name>
    <description>SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</description>
    <arm_group_label>Pulse dose ('sleep mode')</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Dose</intervention_name>
    <description>SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</description>
    <arm_group_label>Continuous dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Males and Females, ages 21-80&#xD;
&#xD;
          2. Current prescription for supplemental oxygen at night; Can be pulsed dose or&#xD;
             continuous&#xD;
&#xD;
          3. Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Medically unstable participants per discretion of the principal investigator&#xD;
&#xD;
          2. Diagnosis of sleep apnea, per chart review, self report or rated high risk based on&#xD;
             the Berlin Questionnaire&#xD;
&#xD;
          3. Participants unable or unwilling to spend one night in a sleep lab&#xD;
&#xD;
          4. Nocturnal oxygen requirements &gt; 5 liters per minute&#xD;
&#xD;
          5. Currently employed by a manufacturer of respiratory products or family member employed&#xD;
             by a manufacturer of respiratory products&#xD;
&#xD;
          6. Employee or family member that is affiliated with Philips&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sukhdev Grover, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Director, Sukhdev Grover and Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sukhdev Grover and Associates</name>
      <address>
        <city>Monroeville</city>
        <state>Pennsylvania</state>
        <zip>15146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <results_first_submitted>October 7, 2016</results_first_submitted>
  <results_first_submitted_qc>October 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 16, 2018</results_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oxygen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Participants</title>
          <description>All Participants enrolled in the study</description>
        </group>
        <group group_id="P2">
          <title>Continuous Dose Then Pulse Dose ('Sleep Mode')</title>
          <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.&#xD;
Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</description>
        </group>
        <group group_id="P3">
          <title>Pulse Dose ('Sleep Mode') Then Continuous Dose</title>
          <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator Pulse Dose (Sleep Mode): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Screening Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>screen failure</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Study Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>11 participants were consented for the trial, after consent 3 were found to be not eligible and 8 continued into the trial and completed.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants</title>
          <description>All Participants enrolled in the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </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="67.76" spread="8.76"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.25" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oxygen Saturation Values Obtained From Pulse Oximetry</title>
        <description>A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Dose</title>
            <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.&#xD;
Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</description>
          </group>
          <group group_id="O2">
            <title>Pulse Dose ('Sleep Mode')</title>
            <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator&#xD;
Pulse Dose (Sleep Mode): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Saturation Values Obtained From Pulse Oximetry</title>
          <description>A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping</description>
          <units>percentage of oxygen saturation (SpO2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Oxygen Saturation (SpO2) while Awake</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6" spread="1.14"/>
                    <measurement group_id="O2" value="95.8" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpO2 while in non rapid eye movement sleep (NREM)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" spread="2.45"/>
                    <measurement group_id="O2" value="96" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpO2 while in rapid eye movement sleep (REM)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="0"/>
                    <measurement group_id="O2" value="97.5" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpO2 over while in bed (TIB (time in bed))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" spread="2.45"/>
                    <measurement group_id="O2" value="96.2" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 night</time_frame>
      <desc>8 participants completed one overnight visit in the lab, during the night participants were monitored for adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Continuous Dose</title>
          <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.&#xD;
Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose</description>
        </group>
        <group group_id="E2">
          <title>Pulse Dose ('Sleep Mode')</title>
          <description>Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator&#xD;
Pulse Dose (Sleep Mode): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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>Chuck Cain</name_or_title>
      <organization>Philips Respironics</organization>
      <phone>+1 724 7335835</phone>
      <email>chuck.cain@philips.com</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/NCT01679301
org study id: HRC-1216-SimGoSleep-SS
nct id: NCT01679301
lead sponsor: 
has dmc: No
The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30
      participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen,
      and meeting all eligibility criteria.
All participants will undergo a single night polysomnography testing in a sleep lab while
      they're oxygen saturation (SpO2) is monitored. The study has a cross-over design, in which
      participants will receive their oxygen prescription in two different modes at different times
      during the night. The assignment (sleep vs. continuous mode) to which participants will
      initiate the night will be randomized, and all participants will utilize each of the two
      modes during the study. The hypothesis of this study is that there will not be a significant
      difference in SpO2 for participants while they use the SimplyGo Portable Oxygen Concentrator,
      set in 'Sleep Mode', or pulsed oxygen flow, as compared to their SpO2 while on continuous
      flow oxygen during sleep during the course of the one night sleep study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Oxygen Saturation Values Obtained From Pulse Oximetry
time frame: Day 1
description: A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
arm group label: Continuous dose
arm group type: Active Comparator
description: Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.
arm group label: Pulse dose ('sleep mode')
arm group type: Experimental
description: Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator
intervention type: Device
intervention name: Pulse Dose (Sleep Mode)
description: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
arm group label: Pulse dose ('sleep mode')
intervention type: Device
intervention name: Continuous Dose
description: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
arm group label: Continuous dose
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sukhdev Grover, MD
role: Principal Investigator
affiliation: Medical Director, Sukhdev Grover and Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 