<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/NCT01678560</url>
  </required_header>
  <id_info>
    <org_study_id>01648</org_study_id>
    <nct_id>NCT01678560</nct_id>
  </id_info>
  <brief_title>Remote Monitoring in Obstructive Sleep Apnea</brief_title>
  <official_title>Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Connecticut Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Connecticut Healthcare System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to&#xD;
      the patient in terms of serious co-morbidities and results in a great cost to the VA Health&#xD;
      Care System to treat the co-morbidities, which include heart disease, stroke and&#xD;
      neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and&#xD;
      studies have shown a poor adherence to treatment. The investigators hypothesize that using&#xD;
      wireless technology will lead to early detection of problems of treatment use and will&#xD;
      translate into early remedial action which will improve the use and effectiveness of&#xD;
      treatment. The investigators will compare two methods. Usual care involves downloading data&#xD;
      from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit.&#xD;
      Wireless care involved more frequent monitoring and intervention in the event of anomalies in&#xD;
      treatment use or effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA)&#xD;
      Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or&#xD;
      unattended home sleep testing was performed at the evaluating clinician's discretion.&#xD;
      Clinicians that saw the patient determined whether PAP therapy was needed, and either&#xD;
      auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were&#xD;
      ordered for the patient. Patients received education about OSA and about their equipment from&#xD;
      a respiratory therapist and physician's assistant within the VA who then provided the&#xD;
      equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider&#xD;
      were screened for participation in the study.The study was overseen by the Institutional&#xD;
      Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut.&#xD;
      Informed consent was obtained from all participants.&#xD;
&#xD;
      Patients were included in the study if they were diagnosed with OSA (defined as AHI or&#xD;
      apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour),&#xD;
      and if they were being exposed to PAP for the first time. Patients who were previously&#xD;
      treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital&#xD;
      admissions (=&lt; 2 weeks), or were living outside cellular network coverage area were excluded&#xD;
      from the study.&#xD;
&#xD;
      Patients that met study inclusion criteria were provided ResMed S9 devices with wireless&#xD;
      modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based&#xD;
      system for the ResMed devices. After the initial setup and educational settings, the patients&#xD;
      received supplies as needed and troubleshooting of side effects of treatment as needed.&#xD;
      Devices were not removed after 3 months if they were not adherent.&#xD;
&#xD;
      Patients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month&#xD;
      intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed&#xD;
      by the clinician at these intervals.&#xD;
&#xD;
      Patients in the wireless care group were monitored more frequently using wireless modems as&#xD;
      the method to obtain adherence and efficacy data.&#xD;
&#xD;
      We then determined adherence using CMS (Centers for Medicare &amp; Medicaid Services) criteria at&#xD;
      3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were&#xD;
      used for 4 or more hours per night on 70% of nights during a consecutive 30-day period&#xD;
      anytime during the first 3 months of initial use, and then a consecutive 30-day period in&#xD;
      months 4-12. We also examined the daily use from the first to last day looking of overall&#xD;
      patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and&#xD;
      maintained in a REDCap database (REDCap is a secure web application for building and managing&#xD;
      online surveys and databases). Sensitivity and specificity calculations were then performed&#xD;
      to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact&#xD;
      test was also used to evaluate the association between adherence at 3 months and 1 year and&#xD;
      the association between AHI (Apnea -Hypopnea Index) and adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment was halted due to the difficulties in recruiting.&#xD;
  </why_stopped>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months</measure>
    <time_frame>First 3 months</time_frame>
    <description>Positive Airway Pressure Treatment Adherence defined as mean PAP use being &gt; 4 hours per night for greater than 70% of nights.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months</measure>
    <time_frame>4-12 Months</time_frame>
    <description>Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being &gt; 4 hours per night for greater than 70% of nights</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receiving Effective Treatment for Obstructive Sleep Apnea</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wireless Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitoring every 3 months by face-to-face visits</intervention_name>
    <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Frequent remote monitoring</intervention_name>
    <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls</description>
    <arm_group_label>Wireless Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed OSA patients&#xD;
&#xD;
          -  AHI of 5/hour or greater&#xD;
&#xD;
          -  Prescribed CPAP therapy&#xD;
&#xD;
          -  Able to comply with treatment and understand treatment instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to understand study requirements&#xD;
&#xD;
          -  Significant cardiorespiratory disease - e.g. COPD (chronic obstructive pulmonary&#xD;
             disease), severe CHF (congestive heart failure)&#xD;
&#xD;
          -  Clinical instability at time of apnea diagnosis&#xD;
&#xD;
          -  Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support&#xD;
             Ventilation), which are other types of PAP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meir Kryger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Connecticut Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Health System</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>September 4, 2018</results_first_submitted>
  <results_first_submitted_qc>December 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 11, 2019</results_first_posted>
  <last_update_submitted>December 10, 2019</last_update_submitted>
  <last_update_submitted_qc>December 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive sleep apnea PAP adherence efficacy economics</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>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.&#xD;
Monitoring every 3 months by face-to-face visits</description>
        </group>
        <group group_id="P2">
          <title>Wireless Care</title>
          <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.&#xD;
Frequent remote monitoring</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.&#xD;
Monitoring every 3 months by face-to-face visits</description>
        </group>
        <group group_id="B2">
          <title>Wireless Care</title>
          <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.&#xD;
Frequent remote monitoring</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months</title>
        <description>Positive Airway Pressure Treatment Adherence defined as mean PAP use being &gt; 4 hours per night for greater than 70% of nights.</description>
        <time_frame>First 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.&#xD;
Monitoring every 3 months by face-to-face visits</description>
          </group>
          <group group_id="O2">
            <title>Wireless Care</title>
            <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.&#xD;
Frequent remote monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months</title>
          <description>Positive Airway Pressure Treatment Adherence defined as mean PAP use being &gt; 4 hours per night for greater than 70% of nights.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Exact Fisher test was used on the collected information from the limited population</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>Exact Fisher test was used on the information from the limited population.</method_desc>
            <param_type>Fisher exact test statistic value</param_type>
            <param_value>1</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>Exact Fisher test was used on the collected information from the limited population.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months</title>
        <description>Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being &gt; 4 hours per night for greater than 70% of nights</description>
        <time_frame>4-12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.&#xD;
Monitoring every 3 months by face-to-face visits</description>
          </group>
          <group group_id="O2">
            <title>Wireless Care</title>
            <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.&#xD;
Frequent remote monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months</title>
          <description>Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being &gt; 4 hours per night for greater than 70% of nights</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Exact Fisher test was used on the collected information from the limited population</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.&#xD;
Exact Fisher test was used on the collected information from the limited population.</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>Exact Fisher test was used on the information from the limited population</method_desc>
            <param_type>Fisher exact test statistic value</param_type>
            <param_value>1</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>Exact Fisher test was used on the collected information from the limited population</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Receiving Effective Treatment for Obstructive Sleep Apnea</title>
        <description>Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.</description>
        <time_frame>12 months</time_frame>
        <population>1 subject from the Wireless group was assigned to Provent treatment. 1 subject from the Usual group was assigned to Dental device treatment. Both subjects stopped using PAP and PAP monitoring and were considered not receiving effective PAP treatment for obstructive sleep apnea. Both subjects were lost in follow-up for our research study.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.&#xD;
Monitoring every 3 months by face-to-face visits</description>
          </group>
          <group group_id="O2">
            <title>Wireless Care</title>
            <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.&#xD;
Frequent remote monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Receiving Effective Treatment for Obstructive Sleep Apnea</title>
          <description>Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.</description>
          <population>1 subject from the Wireless group was assigned to Provent treatment. 1 subject from the Usual group was assigned to Dental device treatment. Both subjects stopped using PAP and PAP monitoring and were considered not receiving effective PAP treatment for obstructive sleep apnea. Both subjects were lost in follow-up for our research study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Exact Fisher test was used on the collected information from the limited population</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Estimation Parameter Other[Fisher exact</param_type>
            <param_value>1</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>PAP Treatment Adherence in the First 3 Months of Treatment Compared to the PAP Treatment Adherence in the Next 9 Months of Treatment</title>
        <description>PAP treatment Adherence in the first 3 months of treatment (according to the CMS - Centers for Medicare &amp; Medicaid Services - criteria) was compared to the PAP treatment Adherence in the next 9 months of treatment to verify the predictability of initial adherence or non-adherence for the future adherence or non-adherence (during the year) to PAP treatment. Adherence/non-adherence was analyzed based on the PAP usage reports (downloads) from the supplied PAP device, based on the yearly, quarterly and monthly portions of the reports.&#xD;
Patient data representing initial adherence or non-adherence and adherence or non-adherence during the year to PAP treatment was collected across both Usual care and Wireless Care Arms.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Initially Adherent Subjects</title>
            <description>Subjects who became Adherent to the PAP treatment according to the CMS criteria within the first 3 months of treatment</description>
          </group>
          <group group_id="O2">
            <title>Initially Non-Adherent Subjects</title>
            <description>Subjects who remained Non-Adherent to the PAP treatment according to the CMS criteria within the first 3 months of treatment</description>
          </group>
        </group_list>
        <measure>
          <title>PAP Treatment Adherence in the First 3 Months of Treatment Compared to the PAP Treatment Adherence in the Next 9 Months of Treatment</title>
          <description>PAP treatment Adherence in the first 3 months of treatment (according to the CMS - Centers for Medicare &amp; Medicaid Services - criteria) was compared to the PAP treatment Adherence in the next 9 months of treatment to verify the predictability of initial adherence or non-adherence for the future adherence or non-adherence (during the year) to PAP treatment. Adherence/non-adherence was analyzed based on the PAP usage reports (downloads) from the supplied PAP device, based on the yearly, quarterly and monthly portions of the reports.&#xD;
Patient data representing initial adherence or non-adherence and adherence or non-adherence during the year to PAP treatment was collected across both Usual care and Wireless Care Arms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Adherent in the next 9 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Adherent in the next 9 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exact Fisher test was used on the collected information from the limited population</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Exact Fisher test was used on the collected information from the limited population</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Other[Fisher exact test statistic value]</param_type>
            <param_value>0.0286</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Exact Fisher test was used on the collected information from the limited population.</estimate_desc>
            <other_analysis_desc>Exact Fisher test was used on the collected information from the limited population.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Adherence and AHI</title>
        <description>PAP adherence in subjects who had more than 20 respiratory events per hour during the initial sleep study was compared with the PAP adherence in subjects who had less than 20 respiratory events per hour during the initial sleep study.Patient data representing subjects who had more than 20 respiratory events per hour during the initial sleep study and subjects who had less than 20 respiratory events per hour during the initial sleep study was collected across both Usual care and Wireless Care Arms.</description>
        <time_frame>1 year/12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AHI More Than 20</title>
            <description>subjects who had more than 20 respiratory events per hour during the initial sleep study</description>
          </group>
          <group group_id="O2">
            <title>AHI Less Than 20</title>
            <description>subjects who had less than 20 respiratory events per hour during the initial sleep study</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence and AHI</title>
          <description>PAP adherence in subjects who had more than 20 respiratory events per hour during the initial sleep study was compared with the PAP adherence in subjects who had less than 20 respiratory events per hour during the initial sleep study.Patient data representing subjects who had more than 20 respiratory events per hour during the initial sleep study and subjects who had less than 20 respiratory events per hour during the initial sleep study was collected across both Usual care and Wireless Care Arms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Adherent in 12 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ANon-Adherent in 12 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exact Fisher test was used on the collected information from the limited population</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Exact Fisher test was used on the collected information from the limited population</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.&#xD;
Exact Fisher test was used on the collected information from the limited population</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>Exact Fisher test was used on the collected information from the limited population</method_desc>
            <param_type>Exact Fisher test</param_type>
            <param_value>0.0039</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>Exact Fisher test was used on the collected information from the limited population</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study</time_frame>
      <desc>The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions.&#xD;
Data was collected during the subject's follow-up and from the medical chart review.</desc>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.&#xD;
Monitoring every 3 months by face-to-face visits</description>
        </group>
        <group group_id="E2">
          <title>Wireless Care</title>
          <description>These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.&#xD;
Frequent remote monitoring</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Wolf -Parkinson-White syndrome. Hospitalization</sub_title>
                <description>Patient with WPW syndrome (Wolff-Parkinson-White syndrome) and previous ablation was hospitalized for sotabol load and discharged from to home in 3 days after achieving the goals of hospitalization with no restriction to physical activity</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hospitalisation due to Dyspnea and Chest Pain on exertion</sub_title>
                <description>A patient with a history of Myocardial Infarction presented with Dyspnea and Chest Pain on exertion. Troponins negative. Underwent nuclear stress test showed normal myocardial perfusion. Discharged home in 3 days</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hospitalization of encephalopathic patient transitioned to comfort care</sub_title>
                <description>Participant with underlying cirrhosis of the liver, lung mass (possible cancer) and hepatocellular carcinoma was taken to a local civilian hospital. He was profoundly encephalopathic and transitioned to comfort care. Reported in mortality section.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Inpatient Psychiatric hospitalization</sub_title>
                <description>Patient has long history of depression and anxiety. Patient stated his anxiety and depression has increased. Pt. Not suicidal, no hallucinations. Discharged in 3 days.Has outpatient psychiatric services.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Elective Laparoscopic repair of incisional hernia</sub_title>
                <description>Laparoscopic repair of incisional hernia complicated by post op ileus. Discharged in 9 days with scheduled follow up</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hospitalization for Elective Laminectomy - Fusion</sub_title>
                <description>Hospitalization for Elective Laminectomy - Fusion</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </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>
    <limitations_and_caveats>CPAP was outsourced eliminating the point of recruitment which halted limiting the study proceeded to the follow-up of recruited patients. Planned statistical data analysis was not performed due to the smaller then expected numbers (expected 220)</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Meir Kryger, MD</name_or_title>
      <organization>Yale University</organization>
      <phone>203-815-0914</phone>
      <email>meir.kryger@yale.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/NCT01678560
org study id: 01648
nct id: NCT01678560
lead sponsor: 
has dmc: No
Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to
      the patient in terms of serious co-morbidities and results in a great cost to the VA Health
      Care System to treat the co-morbidities, which include heart disease, stroke and
      neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and
      studies have shown a poor adherence to treatment. The investigators hypothesize that using
      wireless technology will lead to early detection of problems of treatment use and will
      translate into early remedial action which will improve the use and effectiveness of
      treatment. The investigators will compare two methods. Usual care involves downloading data
      from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit.
      Wireless care involved more frequent monitoring and intervention in the event of anomalies in
      treatment use or effectiveness.
Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA)
      Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or
      unattended home sleep testing was performed at the evaluating clinician's discretion.
      Clinicians that saw the patient determined whether PAP therapy was needed, and either
      auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were
      ordered for the patient. Patients received education about OSA and about their equipment from
      a respiratory therapist and physician's assistant within the VA who then provided the
      equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider
      were screened for participation in the study.The study was overseen by the Institutional
      Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut.
      Informed consent was obtained from all participants.

      Patients were included in the study if they were diagnosed with OSA (defined as AHI or
      apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour),
      and if they were being exposed to PAP for the first time. Patients who were previously
      treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital
      admissions (=< 2 weeks), or were living outside cellular network coverage area were excluded
      from the study.

      Patients that met study inclusion criteria were provided ResMed S9 devices with wireless
      modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based
      system for the ResMed devices. After the initial setup and educational settings, the patients
      received supplies as needed and troubleshooting of side effects of treatment as needed.
      Devices were not removed after 3 months if they were not adherent.

      Patients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month
      intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed
      by the clinician at these intervals.

      Patients in the wireless care group were monitored more frequently using wireless modems as
      the method to obtain adherence and efficacy data.

      We then determined adherence using CMS (Centers for Medicare & Medicaid Services) criteria at
      3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were
      used for 4 or more hours per night on 70% of nights during a consecutive 30-day period
      anytime during the first 3 months of initial use, and then a consecutive 30-day period in
      months 4-12. We also examined the daily use from the first to last day looking of overall
      patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and
      maintained in a REDCap database (REDCap is a secure web application for building and managing
      online surveys and databases). Sensitivity and specificity calculations were then performed
      to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact
      test was also used to evaluate the association between adherence at 3 months and 1 year and
      the association between AHI (Apnea -Hypopnea Index) and adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
time frame: First 3 months
description: Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.
measure: Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months
time frame: 4-12 Months
description: Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being > 4 hours per night for greater than 70% of nights
measure: Receiving Effective Treatment for Obstructive Sleep Apnea
time frame: 12 months
description: Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.
arm group label: Usual Care
arm group type: Active Comparator
description: Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.
arm group label: Wireless Care
arm group type: Active Comparator
description: Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
intervention type: Device
intervention name: Monitoring every 3 months by face-to-face visits
description: These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.
arm group label: Usual Care
intervention type: Device
intervention name: Frequent remote monitoring
description: These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls
arm group label: Wireless Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Meir Kryger, MD
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility: 
country: United States
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: 
limitations and caveats: CPAP was outsourced eliminating the point of recruitment which halted limiting the study proceeded to the follow-up of recruited patients. Planned statistical data analysis was not performed due to the smaller then expected numbers (expected 220)
point of contact: 