<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/NCT03017937</url>
  </required_header>
  <id_info>
    <org_study_id>2016-8580</org_study_id>
    <nct_id>NCT03017937</nct_id>
  </id_info>
  <brief_title>Sex and Age Ultrasound Response to Differential Jugular Vein Pressure</brief_title>
  <official_title>Sex and Age Ultrasound Response to Differential Jugular Vein Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical trials have suggested that this device is effective in mitigating changes in brain&#xD;
      structure and function in athlete populations. The purpose of the current study is to measure&#xD;
      the response of the jugular vein to various pressures applied by a generic compression device&#xD;
      across various ages and gender. The relative jugular vein response will be measured using&#xD;
      ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Device has the promise of providing a novel mechanism for reducing or preventing the&#xD;
      likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the&#xD;
      leading cause of death in individuals under age 45. The cost of TBI in the U.S. is estimated&#xD;
      at anywhere from $50 to $150 billion, annually. Concussion in female high school soccer&#xD;
      players have been noted to occur at a rate of 4.5 concussions per 10,000 athletic exposures&#xD;
      (Comstock, Currie et al. 2015). The investigators propose that Slosh Theory can explain these&#xD;
      differences offering a mechanistic approach that could help shed light on further ways to&#xD;
      alleviate the TBI burden on society. Note that Slosh Theory teaches that hydrodynamics&#xD;
      (fluids moving within moving containers) contribute to, or are even the main etiology for,&#xD;
      energy absorption of the cranial contents and that mitigation of SLOSH (increased&#xD;
      compensatory reserve volume) may mitigate TBI. Significant morbidity, mortality, and related&#xD;
      costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device&#xD;
      worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast&#xD;
      trauma or concussive events, would save lives, and the huge costs currently being experienced&#xD;
      for life-treatment of surviving victims. An externally-worn medical device (the Device) that&#xD;
      applies mild jugular vein compression according to the principle of the Queckenstedt&#xD;
      Maneuver, is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests&#xD;
      that the Device has the potential to reduce the likelihood of TBI. The currently developed&#xD;
      collar (Smith 2009, Smith and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been&#xD;
      approved for studies in humans (IRB 2013-2240) and the results indicate safety for use during&#xD;
      high demand and maximal exertion activities. Regarding safety, the externally worn collar is&#xD;
      meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins&#xD;
      that will provide similar pressure and volume increases not to surpass that of a yawn or the&#xD;
      mere act of just lying down. Initial safety testing and early clinical trials indicate that&#xD;
      the collar application is both safe and efficacious to prevent brain microstructure and&#xD;
      neurophysiological changes in response to head impacts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 2019</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Collar Size</measure>
    <time_frame>1 hour</time_frame>
    <description>measurement of the neck collar size at each pressure level</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Concussion, Mild</condition>
  <arm_group>
    <arm_group_label>Q- collar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Q-collar</intervention_name>
    <description>capture ultrasound images at each pressure point</description>
    <arm_group_label>Q- collar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal healthy volunteer aged 7-60&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
          -  Able to tolerate hypercapnia for 1-2 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
&#xD;
          -  History of neurological deficits, previous cerebral infarction, or severe head trauma&#xD;
             as indicated through pre-season screening:&#xD;
&#xD;
          -  Medical contraindications to restriction of venous outflow via the internal jugular&#xD;
             veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)&#xD;
&#xD;
          -  Glaucoma (Narrow Angle or Normal Tension)&#xD;
&#xD;
          -  Hydrocephalus&#xD;
&#xD;
          -  Recent penetrating brain trauma (within 6 months)&#xD;
&#xD;
          -  Known carotid hypersensitivity&#xD;
&#xD;
          -  Known increased intracranial pressure&#xD;
&#xD;
          -  Central vein thrombosis&#xD;
&#xD;
          -  Any known airway obstruction&#xD;
&#xD;
          -  Any known seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory D Myer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cincinnati Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>July 28, 2020</results_first_submitted>
  <results_first_submitted_qc>October 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2020</results_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</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>Brain Concussion</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>November 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03017937/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 3, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03017937/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Q- Collar</title>
          <description>All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)&#xD;
Q-collar: capture ultrasound images at each pressure point</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Q- Collar</title>
          <description>All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)&#xD;
Q-collar: capture ultrasound images at each pressure point</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="155"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.8" spread="14.80"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average neck size</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Neck Collar Size</title>
        <description>measurement of the neck collar size at each pressure level</description>
        <time_frame>1 hour</time_frame>
        <population>analysis broken down by gender and collar size</population>
        <group_list>
          <group group_id="O1">
            <title>Females</title>
            <description>All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)&#xD;
Q-collar: capture ultrasound images at each pressure point</description>
          </group>
          <group group_id="O2">
            <title>Males</title>
            <description>All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)&#xD;
Q-collar: capture ultrasound images at each pressure point</description>
          </group>
        </group_list>
        <measure>
          <title>Neck Collar Size</title>
          <description>measurement of the neck collar size at each pressure level</description>
          <population>analysis broken down by gender and collar size</population>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Size 11 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.15" spread="0.052"/>
                    <measurement group_id="O2" value="11.11" spread="0.032"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 11 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.25" spread="0.052"/>
                    <measurement group_id="O2" value="11.21" spread="0.032"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 11 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.145" spread="0.052"/>
                    <measurement group_id="O2" value="11.11" spread="0.032"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 12 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.25" spread="0.052"/>
                    <measurement group_id="O2" value="12.28" spread="0.044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 12 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.25" spread="0.052"/>
                    <measurement group_id="O2" value="12.22" spread="0.044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 12 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.25" spread="0.052"/>
                    <measurement group_id="O2" value="12.22" spread="0.044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 13 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.18" spread="0.10"/>
                    <measurement group_id="O2" value="13.23" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 13 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.18" spread="0.101"/>
                    <measurement group_id="O2" value="13.23" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 13 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.24" spread="0.051"/>
                    <measurement group_id="O2" value="13.27" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 14 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.133" spread="0.05"/>
                    <measurement group_id="O2" value="14.156" spread="0.053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 14 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.133" spread="0.05"/>
                    <measurement group_id="O2" value="14.167" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 14 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.167" spread="0.05"/>
                    <measurement group_id="O2" value="14.133" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 15 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.15" spread="0.053"/>
                    <measurement group_id="O2" value="15.14" spread="0.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 15 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" spread="0.107"/>
                    <measurement group_id="O2" value="15.19" spread="0.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 15 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.15" spread="0.053"/>
                    <measurement group_id="O2" value="15.14" spread="0.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 16 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.26" spread="0.052"/>
                    <measurement group_id="O2" value="16.27" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 16 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.24" spread="0.052"/>
                    <measurement group_id="O2" value="16.23" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 16 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.23" spread="0.104"/>
                    <measurement group_id="O2" value="16.24" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 17 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" spread="0"/>
                    <measurement group_id="O2" value="17.15" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 17 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2" spread="0"/>
                    <measurement group_id="O2" value="17.15" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 17 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" spread="0"/>
                    <measurement group_id="O2" value="17.19" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 18 0.75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18.15" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 18 1.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18.15" spread="0.093"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size 18 1.25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18.13" spread="0.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Q- Collar</title>
          <description>All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)&#xD;
Q-collar: capture ultrasound images at each pressure point</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="155"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="155"/>
              </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="155"/>
              </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>Kim Foss</name_or_title>
      <organization>Cincinnati Chidren's Hospital</organization>
      <phone>5136365971</phone>
      <email>kim.foss@cchmc.org</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/NCT03017937
org study id: 2016-8580
nct id: NCT03017937
lead sponsor: 
has dmc: Yes
Clinical trials have suggested that this device is effective in mitigating changes in brain
      structure and function in athlete populations. The purpose of the current study is to measure
      the response of the jugular vein to various pressures applied by a generic compression device
      across various ages and gender. The relative jugular vein response will be measured using
      ultrasound.
The Device has the promise of providing a novel mechanism for reducing or preventing the
      likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the
      leading cause of death in individuals under age 45. The cost of TBI in the U.S. is estimated
      at anywhere from $50 to $150 billion, annually. Concussion in female high school soccer
      players have been noted to occur at a rate of 4.5 concussions per 10,000 athletic exposures
      (Comstock, Currie et al. 2015). The investigators propose that Slosh Theory can explain these
      differences offering a mechanistic approach that could help shed light on further ways to
      alleviate the TBI burden on society. Note that Slosh Theory teaches that hydrodynamics
      (fluids moving within moving containers) contribute to, or are even the main etiology for,
      energy absorption of the cranial contents and that mitigation of SLOSH (increased
      compensatory reserve volume) may mitigate TBI. Significant morbidity, mortality, and related
      costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device
      worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast
      trauma or concussive events, would save lives, and the huge costs currently being experienced
      for life-treatment of surviving victims. An externally-worn medical device (the Device) that
      applies mild jugular vein compression according to the principle of the Queckenstedt
      Maneuver, is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests
      that the Device has the potential to reduce the likelihood of TBI. The currently developed
      collar (Smith 2009, Smith and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been
      approved for studies in humans (IRB 2013-2240) and the results indicate safety for use during
      high demand and maximal exertion activities. Regarding safety, the externally worn collar is
      meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins
      that will provide similar pressure and volume increases not to surpass that of a yawn or the
      mere act of just lying down. Initial safety testing and early clinical trials indicate that
      the collar application is both safe and efficacious to prevent brain microstructure and
      neurophysiological changes in response to head impacts.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Neck Collar Size
time frame: 1 hour
description: measurement of the neck collar size at each pressure level
arm group label: Q- collar
arm group type: Experimental
description: All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)
intervention type: Device
intervention name: Q-collar
description: capture ultrasound images at each pressure point
arm group label: Q- collar
criteria: 
gender: All
minimum age: 7 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Cincinnati Childrens Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 