<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/NCT02973438</url>
  </required_header>
  <id_info>
    <org_study_id>20160818</org_study_id>
    <nct_id>NCT02973438</nct_id>
  </id_info>
  <brief_title>Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI</brief_title>
  <official_title>Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to examine changes in blood glucose control and metabolism in&#xD;
      individuals with SCI and non injured controls at rest and during exercise after five days of&#xD;
      exposure to IH. This response will be compared with breathing normal room air (a SHAM&#xD;
      control).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)</measure>
    <time_frame>Baseline, day 5</time_frame>
    <description>Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of &gt; 1.8 were considered insulin resistant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test</measure>
    <time_frame>Baseline, day 5</time_frame>
    <description>Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Obesity</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (CON) Intermittent Hypoxia then SHAM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (CON) SHAM then Intermittent Hypoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intermittent Hypoxia (IH)</intervention_name>
    <description>Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
    <arm_group_label>Control (CON) Intermittent Hypoxia then SHAM</arm_group_label>
    <arm_group_label>Control (CON) SHAM then Intermittent Hypoxia</arm_group_label>
    <arm_group_label>Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM</arm_group_label>
    <arm_group_label>Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia</arm_group_label>
    <other_name>Hypoxico</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SHAM</intervention_name>
    <description>Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
    <arm_group_label>Control (CON) Intermittent Hypoxia then SHAM</arm_group_label>
    <arm_group_label>Control (CON) SHAM then Intermittent Hypoxia</arm_group_label>
    <arm_group_label>Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM</arm_group_label>
    <arm_group_label>Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        SCI only:&#xD;
&#xD;
          1. Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury&#xD;
             for at least one year.&#xD;
&#xD;
          2. ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI)&#xD;
             (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).&#xD;
&#xD;
        SCI and non injured control:&#xD;
&#xD;
        Resting SaO2 ≥ 95%&#xD;
&#xD;
        Exclusion Criteria (SCI and non injured control):&#xD;
&#xD;
          1. Currently hospitalized&#xD;
&#xD;
          2. Resting heart rate ≥120 BPM&#xD;
&#xD;
          3. Resting systolic blood pressure &gt;180 mm Hg&#xD;
&#xD;
          4. Resting diastolic Blood Pressure &gt;100 mmHg&#xD;
&#xD;
          5. Self-reported history of unstable angina or myocardial infarction within the previous&#xD;
             month&#xD;
&#xD;
          6. Previous cardiac surgery or condition that evidences ischemic heart disease&#xD;
&#xD;
          7. Cardiopulmonary complication such as COPD&#xD;
&#xD;
          8. Pregnancy determined by urine testing in sexually active females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark S Nash, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Miami Project to Cure Paralysis</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>February 26, 2020</results_first_submitted>
  <results_first_submitted_qc>November 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2020</results_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Mark S. Nash, Ph.D., FACSM</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Spinal Cord Injuries</keyword>
  <keyword>Obesity</keyword>
  <keyword>Insulin Resistance</keyword>
  <keyword>Intermittent hypoxia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Insulin Resistance</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>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02973438/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM</title>
          <description>This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="P2">
          <title>Control (CON) Intermittent Hypoxia Then SHAM</title>
          <description>This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="P3">
          <title>Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia</title>
          <description>This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="P4">
          <title>Control (CON) SHAM Then Intermittent Hypoxia</title>
          <description>This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Treatment Session (4 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (Three Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Treatment Session (4 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM</title>
          <description>This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="B2">
          <title>Control (CON) Intermittent Hypoxia Then SHAM</title>
          <description>This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="B3">
          <title>Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia</title>
          <description>This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="B4">
          <title>Control (CON) SHAM Then Intermittent Hypoxia</title>
          <description>This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.&#xD;
SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="1"/>
            <count group_id="B5" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Native Hawaiian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)</title>
        <description>Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of &gt; 1.8 were considered insulin resistant.</description>
        <time_frame>Baseline, day 5</time_frame>
        <population>Unable to obtain blood samples from 2 participants in the control group and 1 participant withdrew prior to the baseline laboratory trial and therefore did not receive any intervention, therefore there is no reported data for the control group.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Injury (SCI) Intermittent Hypoxia</title>
            <description>This arm of individuals with SCI will receive Intermittent Hypoxia (IH). Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
          </group>
          <group group_id="O2">
            <title>Control (CON) Intermittent Hypoxia</title>
            <description>This arm of non injured control subjects will receive Intermittent Hypoxia (IH).&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
          </group>
          <group group_id="O3">
            <title>Spinal Cord Injury (SCI) SHAM</title>
            <description>This arm of individuals with SCI will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
          </group>
          <group group_id="O4">
            <title>Control (CON) SHAM</title>
            <description>This arm of non injured control subjects will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)</title>
          <description>Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of &gt; 1.8 were considered insulin resistant.</description>
          <population>Unable to obtain blood samples from 2 participants in the control group and 1 participant withdrew prior to the baseline laboratory trial and therefore did not receive any intervention, therefore there is no reported data for the control group.</population>
          <units>IR Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.91"/>
                    <measurement group_id="O3" value="1.60" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test</title>
        <description>Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure).</description>
        <time_frame>Baseline, day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Injury (SCI) Intermittent Hypoxia</title>
            <description>This arm of individuals with SCI will receive Intermittent Hypoxia (IH). Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
          </group>
          <group group_id="O2">
            <title>Control (CON) Intermittent Hypoxia</title>
            <description>This arm of non injured control subjects will receive Intermittent Hypoxia (IH).&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
          </group>
          <group group_id="O3">
            <title>Spinal Cord Injury (SCI) SHAM</title>
            <description>This arm of individuals with SCI will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
          </group>
          <group group_id="O4">
            <title>Control (CON) SHAM.</title>
            <description>This arm of non injured control subjects will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test</title>
          <description>Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure).</description>
          <units>% of total energy expenditure.</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.2" spread="25.7"/>
                    <measurement group_id="O2" value="64.9" spread="8.4"/>
                    <measurement group_id="O3" value="51.4" spread="23.6"/>
                    <measurement group_id="O4" value="70.9" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>29 days</time_frame>
      <desc>This study only collected treatment-emergent adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Spinal Cord Injury (SCI) Intermittent Hypoxia</title>
          <description>This arm of individuals with SCI will receive Intermittent Hypoxia (IH). Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
        </group>
        <group group_id="E2">
          <title>Control (CON) Intermittent Hypoxia</title>
          <description>This arm of non injured control subjects will receive Intermittent Hypoxia (IH).&#xD;
Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.</description>
        </group>
        <group group_id="E3">
          <title>Spinal Cord Injury (SCI) SHAM</title>
          <description>This arm of individuals with SCI will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
        <group group_id="E4">
          <title>Control (CON) SHAM.</title>
          <description>This arm of non injured control subjects will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mark S. Nash, Ph.D.</name_or_title>
      <organization>University of Miami</organization>
      <phone>3052433628</phone>
      <email>mnash@med.miami.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02973438
org study id: 20160818
nct id: NCT02973438
lead sponsor: 
has dmc: No
The purpose of this research is to examine changes in blood glucose control and metabolism in
      individuals with SCI and non injured controls at rest and during exercise after five days of
      exposure to IH. This response will be compared with breathing normal room air (a SHAM
      control).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
time frame: Baseline, day 5
description: Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of > 1.8 were considered insulin resistant.
measure: Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
time frame: Baseline, day 5
description: Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure).
arm group label: Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
arm group type: Experimental
description: This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
arm group label: Control (CON) Intermittent Hypoxia then SHAM
arm group type: Experimental
description: This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
arm group label: Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
arm group type: Experimental
description: This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
arm group label: Control (CON) SHAM then Intermittent Hypoxia
arm group type: Experimental
description: This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
intervention type: Device
intervention name: Intermittent Hypoxia (IH)
description: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.
arm group label: Control (CON) Intermittent Hypoxia then SHAM
arm group label: Control (CON) SHAM then Intermittent Hypoxia
arm group label: Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
arm group label: Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
other name: Hypoxico
intervention type: Device
intervention name: SHAM
description: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
arm group label: Control (CON) Intermittent Hypoxia then SHAM
arm group label: Control (CON) SHAM then Intermittent Hypoxia
arm group label: Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
arm group label: Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark S Nash, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Mark S. Nash, Ph.D., FACSM
investigator title: Professor
mesh term: Spinal Cord Injuries
mesh term: Overweight
mesh term: Insulin Resistance
mesh term: Hypoxia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 