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/NCT05971290</url>
    </required_header>
    <id_info>
      <org_study_id>23-0468</org_study_id>
      <nct_id>NCT05971290</nct_id>
    </id_info>
    <brief_title>Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude</brief_title>
    <official_title>Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Colorado, Denver</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Dyspnea and exercise intolerance are well known to travelers who have experienced time at&#xD;
        high elevations, greater than 2500 meters (8200 feet). As individuals ascend to higher&#xD;
        elevations, oxygen saturations significantly decrease as the partial pressure of oxygen&#xD;
        decreases. Additionally, many individuals develop subclinical cases of high altitude&#xD;
        pulmonary edema (HAPE), which may worsen hypoxemia and decrease exercise performance. While&#xD;
        dyspnea and exercise intolerance are usually self-limiting and improve with rest, some&#xD;
        individuals experience severe symptoms that prevent safe evacuation to lower elevation.&#xD;
  &#xD;
        Individuals experiencing high altitude dyspnea, subclinical HAPE, or clinical HAPE will see&#xD;
        improvements in symptoms and SpO2 when receiving supplemental oxygen, however this requires&#xD;
        heavy and unwieldy tanks that make it difficult to carry across irregular terrain.&#xD;
        Additionally, given the often-remote conditions where supplemental oxygen is needed, it is&#xD;
        often difficult to replenish supplies. Other devices, such as the portable hyperbaric chamber&#xD;
        (often referred to as Gamow bag), can temporarily improve dyspnea and oxygen saturation at&#xD;
        high and extreme altitudes without the use of oxygen tanks. This device also carries some of&#xD;
        the same disadvantages as supplemental oxygen, however, as the bag is also heavy and patients&#xD;
        are not ambulatory while using the device.&#xD;
  &#xD;
        Similar to supplemental oxygen and the portable hyperbaric chamber, there is some evidence&#xD;
        that CPAP may improve SpO2 and dyspnea at high and extreme altitudes. CPAP has already&#xD;
        demonstrated significant efficacy in reducing symptoms of acute mountain sickness (AMS) when&#xD;
        used in the field. At the time these small studies were conducted, CPAP therapy carried&#xD;
        similar disadvantages in weight and portability. In recent years, however, CPAP devices have&#xD;
        become increasingly lightweight and portable, with recent models weighing less than 1&#xD;
        kilogram (2.2 pounds). These devices are often powered by batteries, which themselves are&#xD;
        light and easy to carry, and can be charged in the field using either a generator or foldable&#xD;
        solar panels. These newer features of CPAP devices overcome some of the previous&#xD;
        disadvantages that have limited its potential uses. CPAP devices can easily be carried across&#xD;
        difficult terrain directly to individuals suffering from altitude-related symptoms, to be&#xD;
        used as a rescue device until definitive care is available. Its portability not only allows&#xD;
        for easy delivery to a patient, but also may allow for a patient to experience enough symptom&#xD;
        relief to walk themselves down to lower elevation, greatly improving speed and resource&#xD;
        utilization involved in high altitude rescues.&#xD;
  &#xD;
        In previous studies, CPAP devices have been found to be effective and safe to use in high and&#xD;
        extreme altitude locations. While a few pilot studies have assessed CPAP's utility in&#xD;
        treating dyspnea and SpO2 at altitude, these studies were done at rest. While one study&#xD;
        showed improved symptoms and SpO2 in normobaric and hypobaric hypoxia, the study was limited&#xD;
        by its lack of real-world condition, and its authors suggested further study in field and&#xD;
        extreme environmental conditions. Additional investigation is needed to determine whether or&#xD;
        not CPAP is an effective tool in the field to improve SpO2, dyspnea, and exercise tolerance&#xD;
        in individuals traveling at high elevations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">July 22, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peripheral oxygen saturation</measure>
      <time_frame>1 day</time_frame>
      <description>SpO2 measurement in percentage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory rate</measure>
      <time_frame>1 day</time_frame>
      <description>Breaths/minute</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>1 day</time_frame>
      <description>Heartbeats/minute</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Hypoxemia</condition>
    <condition>Altitude Hypoxia</condition>
    <arm_group>
      <arm_group_label>Continuous Positive Airway Pressure use</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Ambient air</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Continuous positive airway pressure</intervention_name>
      <description>Continuous positive airway pressure administered by face mask</description>
      <arm_group_label>Continuous Positive Airway Pressure use</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ambient air</intervention_name>
      <description>Air (fraction of inspired oxygen) at 14000 feet in elevation</description>
      <arm_group_label>Ambient air</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adults (age 18-70)&#xD;
  &#xD;
            -  Living at lower elevation (&lt;2500m or 8200ft)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 70 or age &lt; 18.&#xD;
  &#xD;
            -  History of chronic respiratory conditions (asthma, COPD, ILD)&#xD;
  &#xD;
            -  Obstructive sleep apnea (if currently using nighttime CPAP)&#xD;
  &#xD;
            -  Congestive heart failure, coronary artery disease&#xD;
  &#xD;
            -  History of myocardial infarction&#xD;
  &#xD;
            -  History of HAPE&#xD;
  &#xD;
            -  Neurologic disorder&#xD;
  &#xD;
            -  Cognitive disorder&#xD;
  &#xD;
            -  Altered mental status&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Current use of supplemental oxygen&#xD;
  &#xD;
            -  Impaired mobility&#xD;
  &#xD;
            -  Excessive facial hair&#xD;
  &#xD;
            -  Claustrophobia.&#xD;
  &#xD;
            -  Current use of altitude-related illness prophylaxis medications&#xD;
  &#xD;
            -  Current use of anticoagulant medications&#xD;
  &#xD;
            -  Current use of calcium channel blockers medications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brian M Strickland, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UC Denver</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Colorado Denver</name>
        <address>
          <city>Denver</city>
          <state>Colorado</state>
          <zip>80211</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Altitude Sickness</mesh_term>
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT05971290/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05971290
  org study id: 23-0468
  nct id: NCT05971290
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Dyspnea and exercise intolerance are well known to travelers who have experienced time at
        high elevations, greater than 2500 meters (8200 feet). As individuals ascend to higher
        elevations, oxygen saturations significantly decrease as the partial pressure of oxygen
        decreases. Additionally, many individuals develop subclinical cases of high altitude
        pulmonary edema (HAPE), which may worsen hypoxemia and decrease exercise performance. While
        dyspnea and exercise intolerance are usually self-limiting and improve with rest, some
        individuals experience severe symptoms that prevent safe evacuation to lower elevation.
  
        Individuals experiencing high altitude dyspnea, subclinical HAPE, or clinical HAPE will see
        improvements in symptoms and SpO2 when receiving supplemental oxygen, however this requires
        heavy and unwieldy tanks that make it difficult to carry across irregular terrain.
        Additionally, given the often-remote conditions where supplemental oxygen is needed, it is
        often difficult to replenish supplies. Other devices, such as the portable hyperbaric chamber
        (often referred to as Gamow bag), can temporarily improve dyspnea and oxygen saturation at
        high and extreme altitudes without the use of oxygen tanks. This device also carries some of
        the same disadvantages as supplemental oxygen, however, as the bag is also heavy and patients
        are not ambulatory while using the device.
  
        Similar to supplemental oxygen and the portable hyperbaric chamber, there is some evidence
        that CPAP may improve SpO2 and dyspnea at high and extreme altitudes. CPAP has already
        demonstrated significant efficacy in reducing symptoms of acute mountain sickness (AMS) when
        used in the field. At the time these small studies were conducted, CPAP therapy carried
        similar disadvantages in weight and portability. In recent years, however, CPAP devices have
        become increasingly lightweight and portable, with recent models weighing less than 1
        kilogram (2.2 pounds). These devices are often powered by batteries, which themselves are
        light and easy to carry, and can be charged in the field using either a generator or foldable
        solar panels. These newer features of CPAP devices overcome some of the previous
        disadvantages that have limited its potential uses. CPAP devices can easily be carried across
        difficult terrain directly to individuals suffering from altitude-related symptoms, to be
        used as a rescue device until definitive care is available. Its portability not only allows
        for easy delivery to a patient, but also may allow for a patient to experience enough symptom
        relief to walk themselves down to lower elevation, greatly improving speed and resource
        utilization involved in high altitude rescues.
  
        In previous studies, CPAP devices have been found to be effective and safe to use in high and
        extreme altitude locations. While a few pilot studies have assessed CPAP's utility in
        treating dyspnea and SpO2 at altitude, these studies were done at rest. While one study
        showed improved symptoms and SpO2 in normobaric and hypobaric hypoxia, the study was limited
        by its lack of real-world condition, and its authors suggested further study in field and
        extreme environmental conditions. Additional investigation is needed to determine whether or
        not CPAP is an effective tool in the field to improve SpO2, dyspnea, and exercise tolerance
        in individuals traveling at high elevations.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Peripheral oxygen saturation
  time frame: 1 day
  description: SpO2 measurement in percentage
  measure: Respiratory rate
  time frame: 1 day
  description: Breaths/minute
  measure: Heart rate
  time frame: 1 day
  description: Heartbeats/minute
  arm group label: Continuous Positive Airway Pressure use
  arm group type: Experimental
  arm group label: Ambient air
  arm group type: Sham Comparator
  intervention type: Device
  intervention name: Continuous positive airway pressure
  description: Continuous positive airway pressure administered by face mask
  arm group label: Continuous Positive Airway Pressure use
  intervention type: Device
  intervention name: Ambient air
  description: Air (fraction of inspired oxygen) at 14000 feet in elevation
  arm group label: Ambient air
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Brian M Strickland, MD
  role: Principal Investigator
  affiliation: UC Denver
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Altitude Sickness
  mesh term: Hypoxia
  sharing ipd: No
  provided document: 