<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/NCT01703663</url>
  </required_header>
  <id_info>
    <org_study_id>U037625</org_study_id>
    <nct_id>NCT01703663</nct_id>
  </id_info>
  <brief_title>Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.</brief_title>
  <official_title>Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy&#xD;
      on sleep apnea severity among patients with recent ischemic stroke.&#xD;
&#xD;
      Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as&#xD;
      measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control&#xD;
      night.&#xD;
&#xD;
      Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with&#xD;
      nasal EPAP therapy compared with a control night.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea-hypopnea Index</measure>
    <time_frame>night 1 and night 2</time_frame>
    <description>Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and &gt;= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>EPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Provent Sleep Apnea Therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EPAP</intervention_name>
    <arm_group_label>EPAP</arm_group_label>
    <other_name>Provent Sleep Apnea Therapy.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults with an ischemic stroke (including TIA with infarction) within the prior 14&#xD;
             days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current use of any transnasal tube (eg dobhoff tube)&#xD;
&#xD;
          2. Current use of CPAP, mechanical ventilation, or supplemental oxygen&#xD;
&#xD;
          3. Known severe breathing disorders including hypercapnic respiratory failure,&#xD;
             respiratory muscle weakness, bullous lung disease, bypassed upper airway,&#xD;
             pneumothorax, pneumomediastinum&#xD;
&#xD;
          4. Severe heart disease (including severe heart failure)&#xD;
&#xD;
          5. Pathologically low blood pressure&#xD;
&#xD;
          6. An acute upper respiratory (including nasal, sinus or middle ear) inflammation or&#xD;
             infection, or perforation of the ear drum&#xD;
&#xD;
          7. Sores, abrasions, or skin or mucosal irritation on or around the nose.&#xD;
&#xD;
          8. Known pregnancy&#xD;
&#xD;
          9. Inability to provide informed consent&#xD;
&#xD;
         10. Use of alpha blockers or short acting nitrates&#xD;
&#xD;
         11. Permanent pacemaker&#xD;
&#xD;
         12. Sustained non-sinus cardiac arrhythmia&#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>Devin L Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>May 19, 2016</results_first_submitted>
  <results_first_submitted_qc>August 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 13, 2016</results_first_posted>
  <last_update_submitted>August 19, 2016</last_update_submitted>
  <last_update_submitted_qc>August 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Devin Brown</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Sleep Apnea</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>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Some subjects were discharged from the hospital between the first and second night and therefore dropped out.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>EPAP Therapy First Night, Then Control Night</title>
          <description>During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.</description>
        </group>
        <group group_id="P2">
          <title>Control Night First Night, EPAP Therapy Second Night</title>
          <description>During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </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 Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </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>All subjects who completed both nights</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="55" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index, self reported</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.1" lower_limit="26.6" upper_limit="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NIH Stroke Scale</title>
          <description>total (range 0-42; 0 is no findings)</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" lower_limit="2" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Apnea-hypopnea Index</title>
        <description>Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and &gt;= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.</description>
        <time_frame>night 1 and night 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EPAP Night</title>
            <description>Raw data from EPAP night (not taking into account period effect).</description>
          </group>
          <group group_id="O2">
            <title>Control Night</title>
            <description>Raw data from control night (not taking into account period effect).</description>
          </group>
        </group_list>
        <measure>
          <title>Apnea-hypopnea Index</title>
          <description>Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and &gt;= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.</description>
          <units>apneas plus hypopneas per hour</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" lower_limit="13.2" upper_limit="26.5"/>
                    <measurement group_id="O2" value="25.2" lower_limit="14.2" upper_limit="49.6"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.183</p_value>
            <method>ANOVA</method>
            <param_type>absolute difference</param_type>
            <param_value>-5.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.4</ci_lower_limit>
            <ci_upper_limit>2.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>EPAP Night</title>
        </group>
        <group group_id="E2">
          <title>Control Night</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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>Devin L. Brown, MD, MS</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-936-9075</phone>
      <email>devinb@umich.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/NCT01703663
org study id: U037625
nct id: NCT01703663
lead sponsor: 
has dmc: No
Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy
      on sleep apnea severity among patients with recent ischemic stroke.

      Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as
      measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control
      night.

      Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with
      nasal EPAP therapy compared with a control night.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Apnea-hypopnea Index
time frame: night 1 and night 2
description: Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.
arm group label: EPAP
arm group type: Experimental
description: Provent Sleep Apnea Therapy.
arm group label: control
arm group type: No Intervention
intervention type: Device
intervention name: EPAP
arm group label: EPAP
other name: Provent Sleep Apnea Therapy.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Devin L Brown, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Devin Brown
investigator title: Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Stroke
mesh term: Ischemic Stroke
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 