<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/NCT03300063</url>
  </required_header>
  <id_info>
    <org_study_id>17-002975</org_study_id>
    <nct_id>NCT03300063</nct_id>
  </id_info>
  <brief_title>Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients</brief_title>
  <official_title>Effects of Treating Sleep Apnea-Induced Hypoxemia With Low-Flow Oxygen in Acute Stroke Patients: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      We want to determine if treating acute ischemic stroke patients who have evidence of&#xD;
      hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and&#xD;
      functional outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those&#xD;
      with evidence of hypoxemia will be randomized into two groups. One group will receive&#xD;
      standard medical care. The other group will receive standard medical care as well as&#xD;
      receiving low flow oxygen during sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2018</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard Medical care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Flow Nocturnal Oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive standard medical care as well as low flow oxygen during sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low flow nocturnal oxygen</intervention_name>
    <description>Nocturnal low-flow oxygen via nasal cannula</description>
    <arm_group_label>Low Flow Nocturnal Oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients presenting to Mayo Clinic Hospital with acute ischemic stroke&#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>Melissa C Lipford</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>January 22, 2021</last_update_submitted>
  <last_update_submitted_qc>January 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Melissa Lipford</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hypoxia</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/NCT03300063
org study id: 17-002975
nct id: NCT03300063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We want to determine if treating acute ischemic stroke patients who have evidence of
      hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and
      functional outcomes.
Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those
      with evidence of hypoxemia will be randomized into two groups. One group will receive
      standard medical care. The other group will receive standard medical care as well as
      receiving low flow oxygen during sleep.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Modified Rankin Score
time frame: 3 months
arm group label: control
arm group type: No Intervention
description: Standard Medical care
arm group label: Low Flow Nocturnal Oxygen
arm group type: Active Comparator
description: This group will receive standard medical care as well as low flow oxygen during sleep.
intervention type: Other
intervention name: Low flow nocturnal oxygen
description: Nocturnal low-flow oxygen via nasal cannula
arm group label: Low Flow Nocturnal Oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa C Lipford
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Melissa Lipford
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Hypoxia