<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/NCT02244957</url>
  </required_header>
  <id_info>
    <org_study_id>UCSD140959</org_study_id>
    <nct_id>NCT02244957</nct_id>
  </id_info>
  <brief_title>Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA</brief_title>
  <official_title>Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea&#xD;
      (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S.&#xD;
      population.The investigators propose to conduct this study that aims: (1) to compare right&#xD;
      and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in&#xD;
      overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive&#xD;
      airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)&#xD;
      hemodynamics in overlap syndrome.&#xD;
&#xD;
      This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more&#xD;
      RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and&#xD;
      hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia&#xD;
      alone in patients with overlap syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the high prevalence of overlap syndrome, few data are available on its&#xD;
      pathophysiology and clinical consequences of these patients. Overlap syndrome has recently&#xD;
      been reported to have excess cardiovascular mortality compared with COPD alone. However, no&#xD;
      study has evaluated the mechanisms of excess cardiovascular mortality in untreated overlap&#xD;
      syndrome. In addition, no prospective, randomized, controlled data are currently available on&#xD;
      treatment of overlap syndrome.&#xD;
&#xD;
      This study is divided into two parts. The first part (Part 1) is a cross-sectional cohort&#xD;
      study comparing subjects with overlap syndrome to those with COPD alone and those with OSA&#xD;
      alone. Patients with COPD and OSA overlap syndrome will be evaluated by an overnight sleep&#xD;
      study, cardiac MRI, serum inflammatory biomarker, urine catecholamine level, pulmonary&#xD;
      function test, and questionnaires of sleep and health related quality of life. These&#xD;
      measurement will be compared between overlap syndrome and control groups with either COPD or&#xD;
      OSA alone.&#xD;
&#xD;
      The second part (Part 2) of the study is a prospective, parallel-group, randomized,&#xD;
      controlled pilot study examining the effect of BPAP (and nocturnal oxygen if needed) vs.&#xD;
      nocturnal oxygen therapy alone in patients with overlap syndrome (20 subjects in each&#xD;
      treatment arm). The same measurement done during Part 1 will be repeated to evaluate the&#xD;
      treatment effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2020</completion_date>
  <primary_completion_date type="Actual">February 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Right Ventricular Remodeling Index</measure>
    <time_frame>Six months</time_frame>
    <description>Defined as the ratio between RVMI and RV end-diastolic volume index using MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right Ventricular Mass Index</measure>
    <time_frame>Six months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Ventricular End Systolic and Diastolic Volume</measure>
    <time_frame>Six months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Ventricular Ejection Fraction</measure>
    <time_frame>Six months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Extracellular Volume</measure>
    <time_frame>Six months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Remodeling Index</measure>
    <time_frame>Six months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Mass Index</measure>
    <time_frame>Six months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End Systolic and Diastolic Volume</measure>
    <time_frame>6 months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Ejection Fraction</measure>
    <time_frame>6 months</time_frame>
    <description>MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum C-reactive Protein Level</measure>
    <time_frame>6 months</time_frame>
    <description>blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Tumor Necrosis Factor-alpha Level</measure>
    <time_frame>6 months</time_frame>
    <description>blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Interleukin-6 Level</measure>
    <time_frame>6 months</time_frame>
    <description>blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Intercellular Adhesion Molecule-1</measure>
    <time_frame>6 months</time_frame>
    <description>blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum P-selectin Level</measure>
    <time_frame>6 months</time_frame>
    <description>Blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Catecholamine Level</measure>
    <time_frame>6 months</time_frame>
    <description>Urine test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Distance</measure>
    <time_frame>6 months</time_frame>
    <description>Low-grade physical activity test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health Status Through Short Form 36 (SF-36) Health Survey</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Overlap Syndrome</condition>
  <arm_group>
    <arm_group_label>Bi-level positive airway pressure (BPAP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bi-level positive airway pressure (BPAP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nocturnal oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nocturnal oxygen</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bi-level positive airway pressure (BPAP)</intervention_name>
    <description>Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
    <arm_group_label>Bi-level positive airway pressure (BPAP)</arm_group_label>
    <other_name>BPAP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nocturnal oxygen</intervention_name>
    <description>Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
    <arm_group_label>Nocturnal oxygen</arm_group_label>
    <other_name>NOT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both men and women with age more than 18 years.&#xD;
&#xD;
          -  Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already using continuous positive airway pressure (CPAP), BPAP device, or nocturnal&#xD;
             oxygen.&#xD;
&#xD;
          -  Known or suspected renal failure with estimated Glomerular filtration (GFR) &lt;50&#xD;
             ml/min/1.73 m2 or serum creatinine &gt; 1.5 mg/dl.&#xD;
&#xD;
          -  Chronic atrial fibrillation or frequent premature ventricular contraction (&gt; 10 beats&#xD;
             per hour)&#xD;
&#xD;
          -  Women known to be pregnant or planning to be pregnant in next 6 months.&#xD;
&#xD;
          -  Known contraindication to MRI: cardiac pacemaker, metallic heart valves, metallic&#xD;
             implants, history of claustrophobia.&#xD;
&#xD;
          -  If taking sildenafil or related drugs, unable to stop it within 48 hours of the study&#xD;
             visit.&#xD;
&#xD;
          -  Uncontrolled COPD or acute COPD exacerbation.&#xD;
&#xD;
          -  Unstable cardiac diseases.&#xD;
&#xD;
          -  Known chronic inflammatory diseases like lupus or active infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert L Owens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>May 14, 2020</results_first_submitted>
  <results_first_submitted_qc>July 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2020</results_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Robert L. Owens</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 25, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT02244957/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chronic Obstructive Pulmonary Disease (COPD)</title>
          <description>Subjects with only Chronic Obstructive Pulmonary Disease (COPD)</description>
        </group>
        <group group_id="P2">
          <title>Overlap Syndrome</title>
          <description>Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>one subject was dropped due to lack of efficacy</population>
      <group_list>
        <group group_id="B1">
          <title>Chronic Obstructive Pulmonary Disease (COPD)</title>
          <description>Subjects with only Chronic Obstructive Pulmonary Disease (COPD).</description>
        </group>
        <group group_id="B2">
          <title>Overlap Syndrome</title>
          <description>Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.</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="6"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="22"/>
          </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="64" spread="6.4"/>
                    <measurement group_id="B2" value="63.5" spread="4.2"/>
                    <measurement group_id="B3" value="63.9" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="6"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Right Ventricular Remodeling Index</title>
        <description>Defined as the ratio between RVMI and RV end-diastolic volume index using MRI</description>
        <time_frame>Six months</time_frame>
        <population>one subject was dropped due to lack of efficacy</population>
        <group_list>
          <group group_id="O1">
            <title>Chronic Obstructive Pulmonary Disease (COPD)</title>
            <description>Subjects with only Chronic Obstructive Pulmonary Disease (COPD).</description>
          </group>
          <group group_id="O2">
            <title>Overlap Syndrome</title>
            <description>Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.</description>
          </group>
        </group_list>
        <measure>
          <title>Right Ventricular Remodeling Index</title>
          <description>Defined as the ratio between RVMI and RV end-diastolic volume index using MRI</description>
          <population>one subject was dropped due to lack of efficacy</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3747" spread="0.06335"/>
                    <measurement group_id="O2" value="0.2817" spread="0.03630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Right Ventricular Mass Index</title>
        <description>MRI</description>
        <time_frame>Six months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Right Ventricular Mass Index</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Right Ventricular End Systolic and Diastolic Volume</title>
        <description>MRI</description>
        <time_frame>Six months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Right Ventricular End Systolic and Diastolic Volume</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Right Ventricular Ejection Fraction</title>
        <description>MRI</description>
        <time_frame>Six months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Right Ventricular Ejection Fraction</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Myocardial Extracellular Volume</title>
        <description>MRI</description>
        <time_frame>Six months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Myocardial Extracellular Volume</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Remodeling Index</title>
        <description>MRI</description>
        <time_frame>Six months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Remodeling Index</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Mass Index</title>
        <description>MRI</description>
        <time_frame>Six months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Mass Index</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular End Systolic and Diastolic Volume</title>
        <description>MRI</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular End Systolic and Diastolic Volume</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Ejection Fraction</title>
        <description>MRI</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Ejection Fraction</title>
          <description>MRI</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum C-reactive Protein Level</title>
        <description>blood test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum C-reactive Protein Level</title>
          <description>blood test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Tumor Necrosis Factor-alpha Level</title>
        <description>blood test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Tumor Necrosis Factor-alpha Level</title>
          <description>blood test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Interleukin-6 Level</title>
        <description>blood test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Interleukin-6 Level</title>
          <description>blood test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Intercellular Adhesion Molecule-1</title>
        <description>blood test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Intercellular Adhesion Molecule-1</title>
          <description>blood test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum P-selectin Level</title>
        <description>Blood test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum P-selectin Level</title>
          <description>Blood test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urine Catecholamine Level</title>
        <description>Urine test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Catecholamine Level</title>
          <description>Urine test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6 Minute Walk Distance</title>
        <description>Low-grade physical activity test</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>6 Minute Walk Distance</title>
          <description>Low-grade physical activity test</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)</title>
        <description>Questionnaire</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)</title>
          <description>Questionnaire</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)</title>
        <description>Questionnaire</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)</title>
          <description>Questionnaire</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)</title>
        <description>Questionnaire</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)</title>
          <description>Questionnaire</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>General Health Status Through Short Form 36 (SF-36) Health Survey</title>
        <description>Questionnaire</description>
        <time_frame>6 months</time_frame>
        <population>No data collected as study was terminated prior to randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Bi-level Positive Airway Pressure (BPAP)</title>
            <description>Bi-level positive airway pressure (BPAP)&#xD;
Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations &lt;88% while on stable bi-level settings.</description>
          </group>
          <group group_id="O2">
            <title>Nocturnal Oxygen</title>
            <description>Nocturnal oxygen&#xD;
Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.</description>
          </group>
        </group_list>
        <measure>
          <title>General Health Status Through Short Form 36 (SF-36) Health Survey</title>
          <description>Questionnaire</description>
          <population>No data collected as study was terminated prior to randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Chronic Obstructive Pulmonary Disease (COPD)</title>
          <description>Subjects with only Chronic Obstructive Pulmonary Disease (COPD)</description>
        </group>
        <group group_id="E2">
          <title>Overlap Syndrome</title>
          <description>Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.</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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dillon Gilbertson</name_or_title>
      <organization>UCSD</organization>
      <phone>8582452155</phone>
      <email>dcgilbertson@health.ucsd.edu</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/NCT02244957
org study id: UCSD140959
nct id: NCT02244957
lead sponsor: 
has dmc: No
The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea
      (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S.
      population.The investigators propose to conduct this study that aims: (1) to compare right
      and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in
      overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive
      airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)
      hemodynamics in overlap syndrome.

      This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more
      RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and
      hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia
      alone in patients with overlap syndrome.
Despite the high prevalence of overlap syndrome, few data are available on its
      pathophysiology and clinical consequences of these patients. Overlap syndrome has recently
      been reported to have excess cardiovascular mortality compared with COPD alone. However, no
      study has evaluated the mechanisms of excess cardiovascular mortality in untreated overlap
      syndrome. In addition, no prospective, randomized, controlled data are currently available on
      treatment of overlap syndrome.

      This study is divided into two parts. The first part (Part 1) is a cross-sectional cohort
      study comparing subjects with overlap syndrome to those with COPD alone and those with OSA
      alone. Patients with COPD and OSA overlap syndrome will be evaluated by an overnight sleep
      study, cardiac MRI, serum inflammatory biomarker, urine catecholamine level, pulmonary
      function test, and questionnaires of sleep and health related quality of life. These
      measurement will be compared between overlap syndrome and control groups with either COPD or
      OSA alone.

      The second part (Part 2) of the study is a prospective, parallel-group, randomized,
      controlled pilot study examining the effect of BPAP (and nocturnal oxygen if needed) vs.
      nocturnal oxygen therapy alone in patients with overlap syndrome (20 subjects in each
      treatment arm). The same measurement done during Part 1 will be repeated to evaluate the
      treatment effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Right Ventricular Remodeling Index
time frame: Six months
description: Defined as the ratio between RVMI and RV end-diastolic volume index using MRI
measure: Right Ventricular Mass Index
time frame: Six months
description: MRI
measure: Right Ventricular End Systolic and Diastolic Volume
time frame: Six months
description: MRI
measure: Right Ventricular Ejection Fraction
time frame: Six months
description: MRI
measure: Myocardial Extracellular Volume
time frame: Six months
description: MRI
measure: Left Ventricular Remodeling Index
time frame: Six months
description: MRI
measure: Left Ventricular Mass Index
time frame: Six months
description: MRI
measure: Left Ventricular End Systolic and Diastolic Volume
time frame: 6 months
description: MRI
measure: Left Ventricular Ejection Fraction
time frame: 6 months
description: MRI
measure: Serum C-reactive Protein Level
time frame: 6 months
description: blood test
measure: Serum Tumor Necrosis Factor-alpha Level
time frame: 6 months
description: blood test
measure: Serum Interleukin-6 Level
time frame: 6 months
description: blood test
measure: Serum Intercellular Adhesion Molecule-1
time frame: 6 months
description: blood test
measure: Serum P-selectin Level
time frame: 6 months
description: Blood test
measure: Urine Catecholamine Level
time frame: 6 months
description: Urine test
measure: 6 Minute Walk Distance
time frame: 6 months
description: Low-grade physical activity test
measure: Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)
time frame: 6 months
description: Questionnaire
measure: Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)
time frame: 6 months
description: Questionnaire
measure: Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)
time frame: 6 months
description: Questionnaire
measure: General Health Status Through Short Form 36 (SF-36) Health Survey
time frame: 6 months
description: Questionnaire
arm group label: Bi-level positive airway pressure (BPAP)
arm group type: Active Comparator
description: Bi-level positive airway pressure (BPAP)
arm group label: Nocturnal oxygen
arm group type: Active Comparator
description: Nocturnal oxygen
intervention type: Device
intervention name: Bi-level positive airway pressure (BPAP)
description: Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations <88% while on stable bi-level settings.
arm group label: Bi-level positive airway pressure (BPAP)
other name: BPAP
intervention type: Drug
intervention name: Nocturnal oxygen
description: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.
arm group label: Nocturnal oxygen
other name: NOT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Robert L Owens, MD
role: Principal Investigator
affiliation: UCSD
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Robert L. Owens
investigator title: Assistant Professor
mesh term: Lung Diseases
mesh term: Sleep Apnea Syndromes
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Sleep Apnea, Obstructive
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 