<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/NCT03017859</url>
  </required_header>
  <id_info>
    <org_study_id>RMC-16-0152</org_study_id>
    <nct_id>NCT03017859</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea</brief_title>
  <official_title>High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC)&#xD;
      in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to&#xD;
      continuous positive airway pressure (CPAP) treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single center, prospective study. The study would include 30 patients diagnosed within the&#xD;
      past 2 years with moderate to severe OSA (AHI&gt;=15) at the Rabin Medical Center (RMC) sleep&#xD;
      lab, and who are intolerant to CPAP treatment. Following signing an informed consent form,&#xD;
      these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG&#xD;
      outcome measures will be compared to the baseline PSG done within the past 2 years and to an&#xD;
      additional PSG while connected to a CPAP device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea Hypopnea Index (AHI)</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
    <description>Comparison of HFNC AHI to baseline AHI and to CPAP AHI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of hypoxemia time</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
    <description>O2 saturation (SO2)&lt;90% as measured by pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal SO2%</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events reported while using HFNC</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep efficiency</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sleep time</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Percent rapid eye movement (REM) sleep</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percent Deep sleep</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>User experience with HFNC</measure>
    <time_frame>During at least 2 hours of sleep time</time_frame>
    <description>To be assessed in the following morning with questionnaires</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>High flow nasal cannula treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Airvo 2 device will be used to administer high flow air during the night</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula</intervention_name>
    <description>We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.</description>
    <arm_group_label>High flow nasal cannula treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past&#xD;
             2 years&#xD;
&#xD;
          -  Apnea Hypopnea Index (AHI)≥15&#xD;
&#xD;
          -  Patient has difficulties to adjust or comply with CPAP treatment&#xD;
&#xD;
          -  Signed Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who need bilevel positive airway pressure (BIPAP)&#xD;
&#xD;
          -  Known carbon dioxide (CO2) retainers&#xD;
&#xD;
          -  Weight change&gt;10% compared to time of OSA diagnosis&#xD;
&#xD;
          -  Clinically unstable patients&#xD;
&#xD;
          -  Pregnant women or special populations (e.g. children or patients unable to give&#xD;
             informed consent)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mordechai R Kramer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pulmonary Institute, Rabin Medical Center, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Avraham Unterman, MD</last_name>
    <phone>972-39377221</phone>
    <email>ramiun@clalit.org.il</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>Mordechai Kremer</investigator_full_name>
    <investigator_title>Head of Pulmonary Institute</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03017859
org study id: RMC-16-0152
nct id: NCT03017859
lead sponsor: 
has dmc: Yes
A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC)
      in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to
      continuous positive airway pressure (CPAP) treatment.
A single center, prospective study. The study would include 30 patients diagnosed within the
      past 2 years with moderate to severe OSA (AHI>=15) at the Rabin Medical Center (RMC) sleep
      lab, and who are intolerant to CPAP treatment. Following signing an informed consent form,
      these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG
      outcome measures will be compared to the baseline PSG done within the past 2 years and to an
      additional PSG while connected to a CPAP device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Apnea Hypopnea Index (AHI)
time frame: During at least 2 hours of sleep time
description: Comparison of HFNC AHI to baseline AHI and to CPAP AHI
measure: Percent of hypoxemia time
time frame: During at least 2 hours of sleep time
description: O2 saturation (SO2)<90% as measured by pulse oximeter
measure: Minimal SO2%
time frame: During at least 2 hours of sleep time
measure: Adverse events reported while using HFNC
time frame: During at least 2 hours of sleep time
measure: Sleep efficiency
time frame: During at least 2 hours of sleep time
measure: Total sleep time
time frame: During at least 2 hours of sleep time
measure: Percent rapid eye movement (REM) sleep
time frame: During at least 2 hours of sleep time
measure: Percent Deep sleep
time frame: During at least 2 hours of sleep time
measure: User experience with HFNC
time frame: During at least 2 hours of sleep time
description: To be assessed in the following morning with questionnaires
arm group label: High flow nasal cannula treatment
arm group type: Experimental
description: Airvo 2 device will be used to administer high flow air during the night
intervention type: Device
intervention name: High flow nasal cannula
description: We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.
arm group label: High flow nasal cannula treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mordechai R Kramer, MD
role: Principal Investigator
affiliation: Pulmonary Institute, Rabin Medical Center, Israel
last name: Avraham Unterman, MD
phone: 972-39377221
email: ramiun@clalit.org.il
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: Mordechai Kremer
investigator title: Head of Pulmonary Institute
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No