<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/NCT02250417</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0235</org_study_id>
    <nct_id>NCT02250417</nct_id>
  </id_info>
  <brief_title>Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea</brief_title>
  <official_title>Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hill-Rom</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI&#xD;
      is the number of times per hour of sleep that the airway temporarily collapses at the level&#xD;
      of the tongue or soft palate. In a significant number of individuals with OSA, the severity&#xD;
      of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine&#xD;
      (back) position and lowers in the lateral (side) position. This is called positional OSA.&#xD;
&#xD;
      The primary objective of this study is to determine whether sleeping with a novel sleep&#xD;
      surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those&#xD;
      with positional OSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine whether sleeping with the novel device&#xD;
      (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as&#xD;
      positional OSA. A secondary aim is to determine the effects of the sleep surface on&#xD;
      subjective and objective measures of sleep in patients with positional OSA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea-hypopnea Index (AHI)- Intention to Treat Analysis</measure>
    <time_frame>measured during each of the two sleep study sessions (Study Visits 2 and 3)</time_frame>
    <description>AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.&#xD;
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.&#xD;
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep Quality</measure>
    <time_frame>measured during each of the two sleep study sessions (Study Visits 2 and 3)</time_frame>
    <description>Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Efficiency</measure>
    <time_frame>measured during each of the two sleep study sessions (Study Visits 2 and 3)</time_frame>
    <description>Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>Wave Surface, Then Non Wave Surface</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Wave Surface, Then Wave Surface</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wave sleep surface</intervention_name>
    <description>The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.</description>
    <arm_group_label>Non Wave Surface, Then Wave Surface</arm_group_label>
    <arm_group_label>Wave Surface, Then Non Wave Surface</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        We will recruit subjects who are:&#xD;
&#xD;
          -  18 years of age and above&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
          -  Prior sleep study done based on previous clinical evaluation by the subject's treating&#xD;
             physician in the course of usual clinical care and performed no more than 12 months&#xD;
             prior to enrollment that meets the following:&#xD;
&#xD;
               -  overall AHI 5-30 events/hr&#xD;
&#xD;
               -  at least 20 minutes of recorded sleep in the supine and nonsupine postures&#xD;
&#xD;
               -  positional OSA defined as &gt; 50% reduction in the AHI between the supine and&#xD;
                  nonsupine postures and AHI &lt; 5hr in the nonsupine position&#xD;
&#xD;
               -  central apneas &lt; 50% of the total number of apneas and hypopneas&#xD;
&#xD;
          -  Patients who meet the above criteria who have been prescribed CPAP therapy but are&#xD;
             non-compliant will be enrolled in the study. CPAP noncompliance will be defined as&#xD;
             average nightly use &lt; 4hrs/night based on a download of the CPAP machine, or self-&#xD;
             acknowledged discontinuation of CPAP use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapable of giving informed consent&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Known inability to sleep in the lateral position&#xD;
&#xD;
          -  Active titration of medication&#xD;
&#xD;
          -  Excessive alcohol consumption&#xD;
&#xD;
               -  Excessive alcohol use is defined as:&#xD;
&#xD;
               -  More than 3 glasses of wine a day&#xD;
&#xD;
               -  More than 3 beers a day&#xD;
&#xD;
               -  More than 60 mL of hard liquor a day&#xD;
&#xD;
          -  Room air oxyhemoglobin saturation &lt; 88%&#xD;
&#xD;
          -  Use of home oxygen&#xD;
&#xD;
          -  Compliant with OSA therapy&#xD;
&#xD;
          -  Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score &gt;&#xD;
             16 or a prior history of falling asleep while driving&#xD;
&#xD;
          -  Unstable medical problem such as uncontrolled hypertension.&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 45 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulysses J Magalang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>June 1, 2016</results_first_submitted>
  <results_first_submitted_qc>July 7, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2018</results_first_posted>
  <last_update_submitted>July 7, 2018</last_update_submitted>
  <last_update_submitted_qc>July 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Ulysses Magalang MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <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>Sequence 1</title>
          <description>Participants randomized to Wave Sleep Surface, then to Non Wave Surface</description>
        </group>
        <group group_id="P2">
          <title>Sequence 2</title>
          <description>Participants randomized to Non Wave Sleep Surface, then to the Wave Sleep Surface</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (1 Night)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (1 Night)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This is a randomized cross-over study. The same subject slept with and without the Wave sleep surface.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participanrts</title>
          <description>Participants with positional OSA (based on a previously performed baseline clinical study) were randomized to sleep with or without the Wave sleep surface in a cross-over design. Baseline PSG measures represent values from the previously performed clinical study that qualified subjects to have positional OSA.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </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="48.4" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total AHI</title>
          <units>events/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.4" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>supine AHI</title>
          <units>events/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.1" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>non-supine AHI</title>
          <units>events/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Sleep Time</title>
          <units>mins</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="364.5" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Recording Time</title>
          <units>mins</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="415.7" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sleep Efficiency</title>
          <description>Sleep Efficiency=total sleep time divided by total recording time x100</description>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.6" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Supine Sleep Time</title>
          <units>mins</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153.8" spread="84.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-supine Sleep Time</title>
          <units>mins</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="210.7" spread="79.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage N1 Duration</title>
          <description>Stage N1 is the lightest sleep stage</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.3" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage N2 Duration</title>
          <description>Stage N2 Duration is referred to as the longest sleep stage/largest percentage of sleep time</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="255.8" spread="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage N3 Duration</title>
          <description>Stage N3 is the referred to as &quot;deep sleep&quot; or &quot;slow wave sleep.&quot;</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.1" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage R Duration</title>
          <description>Stage R is the last sleep stage-rapid eye movement (REM)</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.8" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Apnea-hypopnea Index (AHI)- Intention to Treat Analysis</title>
        <description>AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.&#xD;
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.&#xD;
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.</description>
        <time_frame>measured during each of the two sleep study sessions (Study Visits 2 and 3)</time_frame>
        <population>The study compares the difference in AHI within each study subject with and without the use of the Wave Sleep Surface during visit 2 and 3 (intention to treat analysis).</population>
        <group_list>
          <group group_id="O1">
            <title>Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.</description>
          </group>
          <group group_id="O2">
            <title>Non-Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.</description>
          </group>
        </group_list>
        <measure>
          <title>Apnea-hypopnea Index (AHI)- Intention to Treat Analysis</title>
          <description>AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.&#xD;
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.&#xD;
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.</description>
          <population>The study compares the difference in AHI within each study subject with and without the use of the Wave Sleep Surface during visit 2 and 3 (intention to treat analysis).</population>
          <units>events/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="9.4"/>
                    <measurement group_id="O2" value="12.6" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Sleep Quality</title>
        <description>Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.</description>
        <time_frame>measured during each of the two sleep study sessions (Study Visits 2 and 3)</time_frame>
        <population>Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.</description>
          </group>
          <group group_id="O2">
            <title>Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Sleep Quality</title>
          <description>Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.</description>
          <population>Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.</population>
          <units>mins</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Sleep Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="379.8" spread="31.9"/>
                    <measurement group_id="O2" value="363.7" spread="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Recording Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="424.1" spread="34.5"/>
                    <measurement group_id="O2" value="414.3" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage N1 duration(lightest sleep stage)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8" spread="19.1"/>
                    <measurement group_id="O2" value="36.5" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage N2 duration(longest sleep stage)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261.8" spread="34.8"/>
                    <measurement group_id="O2" value="259.3" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>StageN3 duration(deep sleep stage)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="16.0"/>
                    <measurement group_id="O2" value="14.8" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage R duration(Rapid eye movement or REM)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0" spread="23.1"/>
                    <measurement group_id="O2" value="53.1" spread="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Apnea-hypopnea Index (AHI)- Modified Analysis</title>
        <description>AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in breathing per hour of sleep.&#xD;
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.&#xD;
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.&#xD;
The modified analysis compares the AHI within each participant where time spent in the supine position is greater than time spent in non-supine position from either the baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.</description>
        <time_frame>Baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.</time_frame>
        <population>Modified analysis compares the AHI when the time spent in supine position is greater than in the non-supine position either during the baseline sleep study or the non-Wave night.The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.</description>
          </group>
          <group group_id="O2">
            <title>Non-Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface when the time spent in supine position is greater than time spent in non-supine position either during the baseline (inclusion) PSG study or the Non-Wave Sleep Surface night PSG.&#xD;
The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Apnea-hypopnea Index (AHI)- Modified Analysis</title>
          <description>AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in breathing per hour of sleep.&#xD;
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.&#xD;
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.&#xD;
The modified analysis compares the AHI within each participant where time spent in the supine position is greater than time spent in non-supine position from either the baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.</description>
          <population>Modified analysis compares the AHI when the time spent in supine position is greater than in the non-supine position either during the baseline sleep study or the non-Wave night.The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization.</population>
          <units>events/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="9.4"/>
                    <measurement group_id="O2" value="15.9" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Efficiency</title>
        <description>Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.</description>
        <time_frame>measured during each of the two sleep study sessions (Study Visits 2 and 3)</time_frame>
        <population>Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.</description>
          </group>
          <group group_id="O2">
            <title>Wave Night</title>
            <description>Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Efficiency</title>
          <description>Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.</description>
          <population>Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.</population>
          <units>percentage of total recording time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.9" spread="7.8"/>
                    <measurement group_id="O2" value="87.9" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sequence 1</title>
          <description>Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface.&#xD;
Wave sleep surface: The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.</description>
        </group>
        <group group_id="E2">
          <title>Sequence 2</title>
          <description>Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface.&#xD;
Wave sleep surface: The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ulysses J. Magalang</name_or_title>
      <organization>The Ohio State University</organization>
      <phone>614-292-6563</phone>
      <email>magalang.1@osu.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/NCT02250417
org study id: 2014H0235
nct id: NCT02250417
lead sponsor: 
collaborator: 
has dmc: No
Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI
      is the number of times per hour of sleep that the airway temporarily collapses at the level
      of the tongue or soft palate. In a significant number of individuals with OSA, the severity
      of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine
      (back) position and lowers in the lateral (side) position. This is called positional OSA.

      The primary objective of this study is to determine whether sleeping with a novel sleep
      surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those
      with positional OSA.
The primary objective of this study is to determine whether sleeping with the novel device
      (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as
      positional OSA. A secondary aim is to determine the effects of the sleep surface on
      subjective and objective measures of sleep in patients with positional OSA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Apnea-hypopnea Index (AHI)- Intention to Treat Analysis
time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
description: AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.
measure: Objective Sleep Quality
time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
description: Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.
measure: Sleep Efficiency
time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
description: Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.
arm group label: Wave Surface, Then Non Wave Surface
arm group type: Experimental
description: Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface.
arm group label: Non Wave Surface, Then Wave Surface
arm group type: Experimental
description: Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface.
intervention type: Other
intervention name: Wave sleep surface
description: The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.
arm group label: Non Wave Surface, Then Wave Surface
arm group label: Wave Surface, Then Non Wave Surface
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulysses J Magalang, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Ulysses Magalang MD
investigator title: Professor of Medicine
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 