<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/NCT03283072</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201700637</org_study_id>
    <nct_id>NCT03283072</nct_id>
  </id_info>
  <brief_title>Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults</brief_title>
  <acronym>SensoryFLO</acronym>
  <official_title>Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of&#xD;
      sensory effects has been reported.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the strong results of motor studies, the affects of AIH on sensory function has not&#xD;
      been established. We will use a commercially-available hypoxicator that can be programmed to&#xD;
      achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously&#xD;
      published protocols that have generated motor facilitation (and a sham condition) to&#xD;
      characterize and effects on sensory function in healthy adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">July 6, 2020</completion_date>
  <primary_completion_date type="Actual">July 6, 2020</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>
    <intervention_model_description>Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants can't see the device and therefore the settings. The assessment of sensory function is done by a separate investigator who did not participate in the set up of the hypoxicator</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sensory Function</measure>
    <time_frame>Every 10 minutes for 60 minutes post intervention, average reported</time_frame>
    <description>Thermal thresholds. Average reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temporal Sensory Summation</measure>
    <time_frame>Every 10 minutes for 60 minutes post intervention, average reported</time_frame>
    <description>Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, &quot;summation&quot; represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensory Function - Pressure</measure>
    <time_frame>Every 10 minutes for 60 minutes post intervention, average reported</time_frame>
    <description>Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Sensitivity</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention 1</intervention_name>
    <description>15 bouts of 2mins:1min hypoxia:hyperoxia</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention 2</intervention_name>
    <description>15 bouts of 1mins:1min hypoxia:hyperoxia</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention 3</intervention_name>
    <description>8 bouts of 2mins:1min hypoxia:hyperoxia</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention 4 (sham)</intervention_name>
    <description>15 bouts of 1min:1min normoxia</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 40 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery&#xD;
             disease, congenital and valvar heart diseases)&#xD;
&#xD;
          -  Diagnosis of neuromuscular disease&#xD;
&#xD;
          -  Diagnosis of any neurological disease&#xD;
&#xD;
          -  Presence of concurrent medical illness including infection, fractures&#xD;
&#xD;
          -  Diagnosis of obstructive sleep apnea&#xD;
&#xD;
          -  Diagnosis of obstructive/restrictive lung disease&#xD;
&#xD;
          -  Diagnosis of exercise induced asthma&#xD;
&#xD;
          -  FEV1/FVC&lt;80% and/or FVC&lt;80% of predicted value indicating airway obstruction&#xD;
&#xD;
          -  Subjects on prednisolone therapy or selective serotonin reuptake inhibitor (SSRI)&#xD;
             therapy will be excluded from the study as these pharmacological agents are known to&#xD;
             amplify the effects of IH[22, 23]&#xD;
&#xD;
          -  Diagnosis of epilepsy or history of seizures and attention deficit disorders&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  History of coagulation disorders&#xD;
&#xD;
          -  History of chronic pain&#xD;
&#xD;
          -  Body mass index(BMI)&gt; 35kg/m2&#xD;
&#xD;
          -  Subjects on prescription medicines such as beta blockers and other drugs that are&#xD;
             prescribed in any of the exclusionary disorders listed above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark D Bishop, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unversity of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</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>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>June 28, 2021</results_first_submitted>
  <results_first_submitted_qc>August 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2023</results_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 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>thermal threshold</keyword>
  <keyword>pressure pain threshold</keyword>
  <keyword>temporal summation</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>
  <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>March 18, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03283072/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sequence 1</title>
          <description>15 bouts of 2mins:1min hypoxia:hyperoxia&#xD;
15 bouts of 1mins:1min hypoxia:hyperoxia&#xD;
8 bouts of 2mins:1min hypoxia:hyperoxia&#xD;
15 bouts of 1min:1min normoxia</description>
        </group>
        <group group_id="P2">
          <title>Sequence 2</title>
          <description>2. 15 bouts of 1mins:1min hypoxia:hyperoxia 3. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia&#xD;
1. 15 bouts of 2mins:1min hypoxia:hyperoxia</description>
        </group>
        <group group_id="P3">
          <title>Sequence 3</title>
          <description>3. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia&#xD;
15 bouts of 2mins:1min hypoxia:hyperoxia&#xD;
15 bouts of 1mins:1min hypoxia:hyperoxia</description>
        </group>
        <group group_id="P4">
          <title>Sequence 4</title>
          <description>4. 15 bouts of 1min:1min normoxia&#xD;
15 bouts of 2mins:1min hypoxia:hyperoxia&#xD;
15 bouts of 1mins:1min hypoxia:hyperoxia&#xD;
8 bouts of 2mins:1min hypoxia:hyperoxia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <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>Sequence 1</title>
          <description>15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia</description>
        </group>
        <group group_id="B2">
          <title>Sequence 2</title>
          <description>15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia</description>
        </group>
        <group group_id="B3">
          <title>Sequence 3</title>
          <description>8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia</description>
        </group>
        <group group_id="B4">
          <title>Sequence 4</title>
          <description>15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia</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="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" spread="6.3"/>
                    <measurement group_id="B2" value="19.2" spread="1.1"/>
                    <measurement group_id="B3" value="20.8" spread="2.0"/>
                    <measurement group_id="B4" value="20.8" spread="2.1"/>
                    <measurement group_id="B5" value="22.0" spread="5.1"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sensory Function</title>
        <description>Thermal thresholds. Average reported.</description>
        <time_frame>Every 10 minutes for 60 minutes post intervention, average reported</time_frame>
        <population>A 2-way analysis of co-variance with repeated measures (time*intervention) was conducted with gender as the covariate.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention 1</title>
            <description>1) 15 bouts of 1 minute hypoxia:1 minute hyperoxia;</description>
          </group>
          <group group_id="O2">
            <title>Intervention 2</title>
            <description>2) 15 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;</description>
          </group>
          <group group_id="O3">
            <title>Intervention 3</title>
            <description>3) 8 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;</description>
          </group>
          <group group_id="O4">
            <title>Intervention 4 (Sham)</title>
            <description>4) normoxia</description>
          </group>
        </group_list>
        <measure>
          <title>Sensory Function</title>
          <description>Thermal thresholds. Average reported.</description>
          <population>A 2-way analysis of co-variance with repeated measures (time*intervention) was conducted with gender as the covariate.</population>
          <units>Degrees celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" spread="1.5"/>
                    <measurement group_id="O2" value="46.4" spread="1.9"/>
                    <measurement group_id="O3" value="46.1" spread="1.9"/>
                    <measurement group_id="O4" value="45.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.592</p_value>
            <method>ANCOVA</method>
            <method_desc>Within, within repeated measures ANCOVA (gender as co-variate).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temporal Sensory Summation</title>
        <description>Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, &quot;summation&quot; represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.</description>
        <time_frame>Every 10 minutes for 60 minutes post intervention, average reported</time_frame>
        <population>2-way repeated measures ANOVA with gender as the covariate</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention 1</title>
            <description>15 bouts of 1 minute hypoxia:1 minute hyperoxia</description>
          </group>
          <group group_id="O2">
            <title>Intervention 2</title>
            <description>15 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute</description>
          </group>
          <group group_id="O3">
            <title>Intervention 3</title>
            <description>8 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Intervention 4 (Sham)</title>
            <description>normoxia</description>
          </group>
        </group_list>
        <measure>
          <title>Temporal Sensory Summation</title>
          <description>Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, &quot;summation&quot; represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.</description>
          <population>2-way repeated measures ANOVA with gender as the covariate</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="13.3"/>
                    <measurement group_id="O2" value="11.7" spread="10.2"/>
                    <measurement group_id="O3" value="10.9" spread="11.2"/>
                    <measurement group_id="O4" value="11.9" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.721</p_value>
            <method>ANCOVA</method>
            <method_desc>Within, within repeated measures ANCOVA (gender as co-variate).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sensory Function - Pressure</title>
        <description>Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported</description>
        <time_frame>Every 10 minutes for 60 minutes post intervention, average reported</time_frame>
        <population>A 2-way analysis of co-variance with repeated measures (time*intervention) was conducted with gender as the covariate.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention 1</title>
            <description>1. 15 bouts of 2mins:1min hypoxia:hyperoxia</description>
          </group>
          <group group_id="O2">
            <title>Intervention 2</title>
            <description>2. 15 bouts of 1mins:1min hypoxia:hyperoxia</description>
          </group>
          <group group_id="O3">
            <title>Intervention 3</title>
            <description>3. 8 bouts of 2mins:1min hypoxia:hyperoxia</description>
          </group>
          <group group_id="O4">
            <title>Intervention 4 (Sham)</title>
            <description>15 bouts of 1min:1min normoxia</description>
          </group>
        </group_list>
        <measure>
          <title>Sensory Function - Pressure</title>
          <description>Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported</description>
          <population>A 2-way analysis of co-variance with repeated measures (time*intervention) was conducted with gender as the covariate.</population>
          <units>kilograms force</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="3.4"/>
                    <measurement group_id="O2" value="4.6" spread="2.5"/>
                    <measurement group_id="O3" value="4.3" spread="2.8"/>
                    <measurement group_id="O4" value="4.3" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.553</p_value>
            <method>ANCOVA</method>
            <method_desc>Within, within repeated measures ANVOA (gender as covariate)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <desc>The definitions do not differ</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>All participants completed each protocol in a a randomly assigned order. Therefore all adverse event data are combined.&#xD;
15 bouts of 2mins:1min hypoxia:hyperoxia&#xD;
15 bouts of 1mins:1min hypoxia:hyperoxia&#xD;
8 bouts of 2mins:1min hypoxia:hyperoxia&#xD;
15 bouts of 1min:1min normoxia</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="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </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="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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 Bishop</name_or_title>
      <organization>University of Florida</organization>
      <phone>3522736112</phone>
      <email>bish@ufl.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/NCT03283072
org study id: IRB201700637
nct id: NCT03283072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of
      sensory effects has been reported.
Despite the strong results of motor studies, the affects of AIH on sensory function has not
      been established. We will use a commercially-available hypoxicator that can be programmed to
      achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously
      published protocols that have generated motor facilitation (and a sham condition) to
      characterize and effects on sensory function in healthy adults.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Participants can't see the device and therefore the settings. The assessment of sensory function is done by a separate investigator who did not participate in the set up of the hypoxicator
measure: Sensory Function
time frame: Every 10 minutes for 60 minutes post intervention, average reported
description: Thermal thresholds. Average reported.
measure: Temporal Sensory Summation
time frame: Every 10 minutes for 60 minutes post intervention, average reported
description: Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
measure: Sensory Function - Pressure
time frame: Every 10 minutes for 60 minutes post intervention, average reported
description: Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
arm group label: Sequence 1
arm group type: Experimental
description: Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham)
arm group label: Sequence 2
arm group type: Experimental
description: Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia
arm group label: Sequence 3
arm group type: Experimental
description: Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia
arm group label: Sequence 4
arm group type: Experimental
description: 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia
intervention type: Device
intervention name: Intervention 1
description: 15 bouts of 2mins:1min hypoxia:hyperoxia
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
intervention type: Device
intervention name: Intervention 2
description: 15 bouts of 1mins:1min hypoxia:hyperoxia
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
intervention type: Device
intervention name: Intervention 3
description: 8 bouts of 2mins:1min hypoxia:hyperoxia
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
intervention type: Device
intervention name: Intervention 4 (sham)
description: 15 bouts of 1min:1min normoxia
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark D Bishop, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 