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/NCT05984186</url>
    </required_header>
    <id_info>
      <org_study_id>RP-VTPF2022001Sci</org_study_id>
      <nct_id>NCT05984186</nct_id>
    </id_info>
    <brief_title>Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline</brief_title>
    <official_title>Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vapotherm, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Auburn University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vapotherm, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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 study will evaluate the impact of high velocity therapy (HVT) on reduction of work of&#xD;
        breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery&#xD;
        from a Wingate-type Exercise test. The study will include four study segments, corresponding&#xD;
        to four different therapy settings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        HVT has been found to be a useful clinical tool for treatment of Type 1 and Type 2&#xD;
        respiratory failure (including hypercapnic respiratory failure), acute decompensated heart&#xD;
        failure, and COVID respiratory complications. The overall objective of this prospective,&#xD;
        pilot study is to evaluate whether HVT might enhance the decline of blood lactate&#xD;
        concentrations following a high intensity exercise bout, in healthy volunteers. The&#xD;
        hypothesis is that HVT, regardless of the oxygen concentration (i.e., FiO2), will reduce the&#xD;
        work of breathing and increase the lactate clearance rate during exercise and recovery&#xD;
        intervals. This pilot study could ignite further research providing HVT applications to high&#xD;
        performing athletics and patients in an acute care setting requiring physical rehabilitation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Blood lactate change</measure>
      <time_frame>From exercise test through recovery period, 60 min</time_frame>
      <description>The change in blood lactate starting from the exercise test throughout the recovery period</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">15</enrollment>
    <condition>Dyspnea</condition>
    <condition>Lactic Acidosis</condition>
    <condition>Muscle</condition>
    <condition>Breathlessness</condition>
    <condition>Exercise</condition>
    <condition>Recovery</condition>
    <arm_group>
      <arm_group_label>low flow on room air</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>low flow on oxygen</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>high flow on room air</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>high flow with oxygen</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high velocity therapy</intervention_name>
      <description>4 different flow settings and FIO2</description>
      <arm_group_label>high flow on room air</arm_group_label>
      <arm_group_label>high flow with oxygen</arm_group_label>
      <arm_group_label>low flow on oxygen</arm_group_label>
      <arm_group_label>low flow on room air</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be solicited by investigators and consented prior to participation. Once&#xD;
          consented, participants will be scheduled for their testing session(s) per protocol&#xD;
          procedures. If enrolled, participants will be randomized to the order of the different&#xD;
          settings on the HVT 2.0 device in different test sessions. Each participant will present on&#xD;
          4 different days for testing. This is to avoid fatigue related changes in sequential tests.&#xD;
          Additional testing sessions may be scheduled to complete data collection if needed.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males or females between the ages of 18-30 years, in a general state of good health&#xD;
  &#xD;
            -  No known contraindication to performing a maximal exercise test, i.e., Wingate-type&#xD;
               Anaerobic exercise test&#xD;
  &#xD;
            -  Participants must consider themselves able to perform &quot;regular moderate&quot; or &quot;regular&#xD;
               strenuous&quot; exercise.&#xD;
  &#xD;
                 -  &quot;Regular moderate&quot; exercise includes less than 30 minutes every day or 30 minutes&#xD;
                    every other day, of some form of deliberate exercise, that does not include&#xD;
                    walking.&#xD;
  &#xD;
                 -  &quot;Regular strenuous&quot; exercise is 30+ minutes per day, of some form of deliberate&#xD;
                    exercise, that does not include walking.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not considered a 'high-performance athlete'&#xD;
  &#xD;
            -  Known active cardiovascular, metabolic, liver, or renal disease&#xD;
  &#xD;
            -  Orthopedic limitations to exercise&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Use of beta-blockers or beta-agonist asthma medications&#xD;
  &#xD;
            -  Exercise induced asthma&#xD;
  &#xD;
            -  Any other health-related issue that would involve the participant's fitness capability&#xD;
  &#xD;
            -  Inability to complete all of the study procedures&#xD;
  &#xD;
            -  No heart or breathing condition&#xD;
  &#xD;
            -  No chest pain during activities of daily living of exercise&#xD;
  &#xD;
            -  No dizziness or loss of balance or consciousness during the previous 12 months&#xD;
  &#xD;
            -  Not a smoker&#xD;
  &#xD;
            -  No history of blood clots, known bleeding disorders, and must not be taking Coumadin&#xD;
               or other blood thinners such as Brilinta, Effient, Eliquis, Plavix, Pradaxa, Savaysa,&#xD;
               Xarelto, or an aspirin regimen&#xD;
  &#xD;
            -  Not diabetic&#xD;
  &#xD;
            -  Free of any medical condition that would contraindicate participating in intense&#xD;
               exercise or&#xD;
  &#xD;
            -  donating a skeletal muscle biopsy (i.e. blood clotting disorder or taking blood&#xD;
               thinners)&#xD;
  &#xD;
            -  Not allergic to Lidocaine or other &quot;caine&quot; anesthetics (for example, lignocaine,&#xD;
               prilocaine, bupivacaine or others), or heparin&#xD;
  &#xD;
            -  No chronic medical condition that might cause exercise to be risky&#xD;
  &#xD;
            -  No bone, joint, or soft tissue problem that could be made worse by participation in&#xD;
               the study&#xD;
  &#xD;
            -  Not allergic to latex or adhesives&#xD;
  &#xD;
            -  No restriction to comfortable breathing through the nose&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bruce Gladden</last_name>
      <role>Principal Investigator</role>
      <affiliation>Auburn University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Michael Roberts</last_name>
      <role>Principal Investigator</role>
      <affiliation>Auburn University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Max Michael</last_name>
      <role>Principal Investigator</role>
      <affiliation>Auburn University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nina Stute</last_name>
      <role>Principal Investigator</role>
      <affiliation>Auburn University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Auburn University</name>
        <address>
          <city>Auburn</city>
          <state>Alabama</state>
          <zip>36849</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 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>Dyspnea</mesh_term>
      <mesh_term>Acidosis</mesh_term>
      <mesh_term>Acidosis, Lactic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05984186
  org study id: RP-VTPF2022001Sci
  nct id: NCT05984186
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of
        breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery
        from a Wingate-type Exercise test. The study will include four study segments, corresponding
        to four different therapy settings.
  HVT has been found to be a useful clinical tool for treatment of Type 1 and Type 2
        respiratory failure (including hypercapnic respiratory failure), acute decompensated heart
        failure, and COVID respiratory complications. The overall objective of this prospective,
        pilot study is to evaluate whether HVT might enhance the decline of blood lactate
        concentrations following a high intensity exercise bout, in healthy volunteers. The
        hypothesis is that HVT, regardless of the oxygen concentration (i.e., FiO2), will reduce the
        work of breathing and increase the lactate clearance rate during exercise and recovery
        intervals. This pilot study could ignite further research providing HVT applications to high
        performing athletics and patients in an acute care setting requiring physical rehabilitation.
  observational model: Other
  time perspective: Prospective
  measure: Blood lactate change
  time frame: From exercise test through recovery period, 60 min
  description: The change in blood lactate starting from the exercise test throughout the recovery period
  arm group label: low flow on room air
  arm group label: low flow on oxygen
  arm group label: high flow on room air
  arm group label: high flow with oxygen
  intervention type: Device
  intervention name: high velocity therapy
  description: 4 different flow settings and FIO2
  arm group label: high flow on room air
  arm group label: high flow with oxygen
  arm group label: low flow on oxygen
  arm group label: low flow on room air
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bruce Gladden
  role: Principal Investigator
  affiliation: Auburn University
  last name: Michael Roberts
  role: Principal Investigator
  affiliation: Auburn University
  last name: Max Michael
  role: Principal Investigator
  affiliation: Auburn University
  last name: Nina Stute
  role: Principal Investigator
  affiliation: Auburn University
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Dyspnea
  mesh term: Acidosis
  mesh term: Acidosis, Lactic
  sharing ipd: Undecided