xml: <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/NCT06000332</url>
    </required_header>
    <id_info>
      <org_study_id>INO-05</org_study_id>
      <nct_id>NCT06000332</nct_id>
    </id_info>
    <brief_title>Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia</brief_title>
    <official_title>Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inogen Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inogen Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen&#xD;
        Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night&#xD;
        and examine whether the device can adequately maintain oxygen saturation during sleep.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study design is a prospective, single site, single arm, open label, pilot study. The aim&#xD;
        of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on&#xD;
        peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine&#xD;
        whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve&#xD;
        target with initial titration setting and/or with any needed adjustments of setting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">October 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 24, 2023</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>Number/% of subjects that could achieve SpO2 ≥90% for &gt;30% of sleep time</measure>
      <time_frame>6 hours overnight</time_frame>
      <description>oxygen saturation (SpO2)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number/% of subjects requiring increased settings and the difference between initial and maximal settings required to meet target SpO2 ≥90% for &gt;30% of sleep time criteria</measure>
      <time_frame>6 hours overnight</time_frame>
      <description>oxygen saturation (SpO2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time/% time above/below 90% target on initial setting and maximal setting</measure>
      <time_frame>6 hours overnight</time_frame>
      <description>oxygen saturation (SpO2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting</measure>
      <time_frame>6 hours overnight</time_frame>
      <description>oxygen saturation (SpO2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimum/maximum SpO2 on initial setting and maximal setting</measure>
      <time_frame>6 hours overnight</time_frame>
      <description>oxygen saturation (SpO2)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Nocturnal Hypoxemia</condition>
    <arm_group>
      <arm_group_label>InogenOne Rove 6 Portable Oxygen Concentrator</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>InogenOne Rove 6 Portable Oxygen Concentrator</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>InogenOne Rove 6 Portable Oxygen Concentrator</intervention_name>
      <description>overnight use of Portable Oxygen Concentrator, 6 hours minimum</description>
      <arm_group_label>InogenOne Rove 6 Portable Oxygen Concentrator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects may be of any gender&#xD;
  &#xD;
            2. Subject's age must be 40 - 80 years&#xD;
  &#xD;
            3. Subjects must have a current prescription for nocturnal oxygen &lt; 3 L/min continuous or&#xD;
               current use of a Portable Oxygen Concentrator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject is using any ancillary medical device(s) that may interfere with the operation&#xD;
               of or data interpretation from the InogenOne device (such as CPAP/BiPAP, NIV).&#xD;
  &#xD;
            2. Subjects with nasal obstruction&#xD;
  &#xD;
            3. Subjects taking any drugs that affect respiratory center drive&#xD;
  &#xD;
            4. Subject has an acute illness or hospitalization within the last 30 days&#xD;
  &#xD;
            5. Subject has a change in medication within the last 15 days&#xD;
  &#xD;
            6. Subject is currently receiving respiratory stimulant medications (such as&#xD;
               acetazolamide, medroxyprogresterone, doxapram, theophylline/aminophylline,&#xD;
               protriptyline and buspirone)&#xD;
  &#xD;
            7. Subject has significant comorbidities that in the opinion of the Investigator would&#xD;
               interfere with outcomes and/or study conduct&#xD;
  &#xD;
            8. Subject's prescribed treatment is in conflict with study procedures&#xD;
  &#xD;
            9. Subjects with any unstable disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stanislav Glezer, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Inogen Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alan Kamada, PharmD</last_name>
      <phone>984-309-9037</phone>
      <email>akamada@inogen.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stanislav Glezer, MD</last_name>
      <phone>609-454-7955</phone>
      <email>stan.glezer@inogen.net</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hypoxemia, oxygen</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000332
  org study id: INO-05
  nct id: NCT06000332
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen
        Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night
        and examine whether the device can adequately maintain oxygen saturation during sleep.
  The study design is a prospective, single site, single arm, open label, pilot study. The aim
        of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on
        peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine
        whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve
        target with initial titration setting and/or with any needed adjustments of setting.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
  time frame: 6 hours overnight
  description: oxygen saturation (SpO2)
  measure: Number/% of subjects requiring increased settings and the difference between initial and maximal settings required to meet target SpO2 ≥90% for >30% of sleep time criteria
  time frame: 6 hours overnight
  description: oxygen saturation (SpO2)
  measure: Time/% time above/below 90% target on initial setting and maximal setting
  time frame: 6 hours overnight
  description: oxygen saturation (SpO2)
  measure: Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
  time frame: 6 hours overnight
  description: oxygen saturation (SpO2)
  measure: Minimum/maximum SpO2 on initial setting and maximal setting
  time frame: 6 hours overnight
  description: oxygen saturation (SpO2)
  arm group label: InogenOne Rove 6 Portable Oxygen Concentrator
  arm group type: Experimental
  description: InogenOne Rove 6 Portable Oxygen Concentrator
  intervention type: Device
  intervention name: InogenOne Rove 6 Portable Oxygen Concentrator
  description: overnight use of Portable Oxygen Concentrator, 6 hours minimum
  arm group label: InogenOne Rove 6 Portable Oxygen Concentrator
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Stanislav Glezer, MD
  role: Study Chair
  affiliation: Inogen Inc.
  last name: Alan Kamada, PharmD
  phone: 984-309-9037
  email: akamada@inogen.net
  last name: Stanislav Glezer, MD
  phone: 609-454-7955
  email: stan.glezer@inogen.net
  responsible party type: Sponsor
  mesh term: Hypoxia
  sharing ipd: No