<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/NCT04458779</url>
  </required_header>
  <id_info>
    <org_study_id>109018-E</org_study_id>
    <nct_id>NCT04458779</nct_id>
  </id_info>
  <brief_title>CPAP on Acute Stroke and OSA</brief_title>
  <official_title>Cardiovascular Effects of Continuous Positive Airway Pressure in Patients With Acute Stroke and Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke affects 16.9 million individuals each year and is the second leading cause of death&#xD;
      worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of&#xD;
      hospitalization for stroke remain high. These data emphasize the importance of identifying&#xD;
      all treatable conditions that could aggravate stroke. One such condition is obstructive sleep&#xD;
      apnea (OSA).&#xD;
&#xD;
      Sleep-related breathing disorders, including obstructive and central sleep apnea, often&#xD;
      coexist with stroke. Compared to the general population, in whom OSA is the most common form&#xD;
      of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female&#xD;
      , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized&#xD;
      controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating&#xD;
      OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes,&#xD;
      accelerated neurological recovery.Apart from the benefits in better neurological outcomes,&#xD;
      secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce&#xD;
      recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control&#xD;
      studies to prove CPAP treatment would reduce the recurrence of cardiovascular or&#xD;
      cerebrovascular events.&#xD;
&#xD;
      Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented&#xD;
      mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke&#xD;
      as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can&#xD;
      serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a&#xD;
      growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA.&#xD;
      Notably, all of these studies above are observational or retrospective in nature. To date,&#xD;
      there are no prospective longitudinal randomized controlled trials reporting the effect of&#xD;
      CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized ,&#xD;
      controlled trial involving patients with stroke to test the primary hypothesis that treatment&#xD;
      of OSA with CPAP would reduce the size of LA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in left atrium volume index (LAVI)</measure>
    <time_frame>12 months</time_frame>
    <description>Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serial change of NT-proBNP</measure>
    <time_frame>12 months</time_frame>
    <description>Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological and functional assessments-1</measure>
    <time_frame>12 months</time_frame>
    <description>Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological and functional assessments-2</measure>
    <time_frame>12 months</time_frame>
    <description>Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological and functional assessments-3</measure>
    <time_frame>12 months</time_frame>
    <description>Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life assessments</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Numbers of cardiovascular or cerebrovascular events</measure>
    <time_frame>12 months</time_frame>
    <description>Numbers of cardiovascular or cerebrovascular events post randomization</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to cardiovascular or cerebrovascular events</measure>
    <time_frame>12 months</time_frame>
    <description>Time to cardiovascular or cerebrovascular events post randomization</description>
  </other_outcome>
  <other_outcome>
    <measure>Numbers of all-cause hospitalizations</measure>
    <time_frame>12 months</time_frame>
    <description>Numbers of hospitalizations for any reason post randomization</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of deaths</measure>
    <time_frame>12 months</time_frame>
    <description>Numbers of deaths from all causes post randomization</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to deaths</measure>
    <time_frame>12 months</time_frame>
    <description>Time to deaths from all causes post randomization</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke, Acute</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>CPAP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual-care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive optimal standard therapy for acute stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CPAP</intervention_name>
    <description>CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.</description>
    <arm_group_label>CPAP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Time from onset of stroke symptoms to hospital arrival &lt;2 weeks .&#xD;
&#xD;
          2. Stroke is documented with brain magnetic imaging or computed tomography&#xD;
&#xD;
          3. Competency to provide informed consent.&#xD;
&#xD;
          4. Moderate to severe obstructive sleep apnea being established with the use of a home&#xD;
             sleep-study screening device (ApneaLink).&#xD;
&#xD;
          5. Epworth sleepiness scale≦10.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Having received CPAP for obstructive sleep apnea prior to admission.&#xD;
&#xD;
          2. History of pneumothorax or brain surgery.&#xD;
&#xD;
          3. Coexisting heart failure or renal failure or persistent atrial fibrillation.&#xD;
&#xD;
          4. Unable to wear a nasal or nasal-oral mask.&#xD;
&#xD;
          5. Concomitant uncontrolled infection.&#xD;
&#xD;
          6. Swallowing difficulty or episodes of choking due to stroke&#xD;
&#xD;
          7. Coexisting central nervous diseases such as dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pei-Chen Lai, BD</last_name>
    <phone>8966-7000</phone>
    <phone_ext>1551</phone_ext>
    <email>sleepra01@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pei-Chen Lai</last_name>
      <phone>8966-7000</phone>
      <phone_ext>1551</phone_ext>
      <email>sleepra01@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chou-Han Lin</investigator_full_name>
    <investigator_title>Principical investigator</investigator_title>
  </responsible_party>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>stroke</keyword>
  <keyword>continuous positive airway pressure</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>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04458779
org study id: 109018-E
nct id: NCT04458779
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stroke affects 16.9 million individuals each year and is the second leading cause of death
      worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of
      hospitalization for stroke remain high. These data emphasize the importance of identifying
      all treatable conditions that could aggravate stroke. One such condition is obstructive sleep
      apnea (OSA).

      Sleep-related breathing disorders, including obstructive and central sleep apnea, often
      coexist with stroke. Compared to the general population, in whom OSA is the most common form
      of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female
      , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized
      controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating
      OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes,
      accelerated neurological recovery.Apart from the benefits in better neurological outcomes,
      secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce
      recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control
      studies to prove CPAP treatment would reduce the recurrence of cardiovascular or
      cerebrovascular events.

      Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented
      mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke
      as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can
      serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a
      growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA.
      Notably, all of these studies above are observational or retrospective in nature. To date,
      there are no prospective longitudinal randomized controlled trials reporting the effect of
      CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized ,
      controlled trial involving patients with stroke to test the primary hypothesis that treatment
      of OSA with CPAP would reduce the size of LA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in left atrium volume index (LAVI)
time frame: 12 months
description: Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.
measure: Serial change of NT-proBNP
time frame: 12 months
description: Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.
measure: Neurological and functional assessments-1
time frame: 12 months
description: Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.
measure: Neurological and functional assessments-2
time frame: 12 months
description: Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.
measure: Neurological and functional assessments-3
time frame: 12 months
description: Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.
measure: Change in Quality of life assessments
time frame: 12 months
description: Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.
measure: Numbers of cardiovascular or cerebrovascular events
time frame: 12 months
description: Numbers of cardiovascular or cerebrovascular events post randomization
measure: Time to cardiovascular or cerebrovascular events
time frame: 12 months
description: Time to cardiovascular or cerebrovascular events post randomization
measure: Numbers of all-cause hospitalizations
time frame: 12 months
description: Numbers of hospitalizations for any reason post randomization
measure: Number of deaths
time frame: 12 months
description: Numbers of deaths from all causes post randomization
measure: Time to deaths
time frame: 12 months
description: Time to deaths from all causes post randomization
arm group label: CPAP group
arm group type: Experimental
description: Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke.
arm group label: Usual-care group
arm group type: No Intervention
description: Subjects will receive optimal standard therapy for acute stroke.
intervention type: Device
intervention name: CPAP
description: CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.
arm group label: CPAP group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pei-Chen Lai, BD
phone: 8966-7000
phone ext: 1551
email: sleepra01@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Chou-Han Lin
investigator title: Principical investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Stroke