<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/NCT02262507</url>
  </required_header>
  <id_info>
    <org_study_id>2013-5717</org_study_id>
    <nct_id>NCT02262507</nct_id>
  </id_info>
  <brief_title>Concussion Device Audiological Measures</brief_title>
  <official_title>Concussion Device Audiological Measures</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>
      Significant morbidity, mortality, and related costs are caused by traumatic brain injury&#xD;
      (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the&#xD;
      field, designed to mitigate TBI resulting from blast trauma or concussive events, would save&#xD;
      lives, and the huge costs currently being experienced for life-treatment of surviving&#xD;
      victims. An externally-worn medical device that applies mild jugular compression according to&#xD;
      the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC&#xD;
      (Q30). Initial research suggests that the Device has the potential to reduce the likelihood&#xD;
      of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is&#xD;
      that the investigators need a physiologic, non-invasive method to evaluate the brain&#xD;
      responses to mild jugular compression across multiple age groups. To determine this with MR&#xD;
      imaging is currently cost prohibitive. The investigators pilot data from the parent IRB&#xD;
      indicates a consistent response measured via wideband absorbance in young adults. Therefore,&#xD;
      a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ&#xD;
      this technology across a wide range of ages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the testing sessions, subjects may either come to our testing site or the investigators&#xD;
      may bring the testing to their location (e.g. schools, work). The subjects will be fitted&#xD;
      with a device around your neck, like a neck tie. The Device incorporates two bulges localized&#xD;
      over the site of the internal jugular veins bilaterally. Experiments performed with jugular&#xD;
      Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins&#xD;
      are reduced, while flow within the carotid arteries and all portions of the cerebrum are&#xD;
      preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will&#xD;
      not cause any untoward health risks (IRB# 2013-2240 safety testing performed on this Device).&#xD;
      The pressure exerted by the Device on the region of the neck superficial to the internal&#xD;
      jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting&#xD;
      necktie. The methods are utilized in prior approved IRB (2013-2240)..&#xD;
&#xD;
      Station I: Consent to Participate Each participant will review the Institutional Review Board&#xD;
      approved consent to participate form prior to data collection. They will be given an adequate&#xD;
      amount of time to ask questions to the study coordinator, or the person obtaining consent,&#xD;
      and then make their decision to participate or not participate. If they wish to participate,&#xD;
      they will be asked to sign the informed consent form. For middle school and high school&#xD;
      subjects recruited via the investigators relationship with the schools, this station will be&#xD;
      designated to review consent and assent forms to ensure that proper signatures have been&#xD;
      obtained.&#xD;
&#xD;
      Station II: Device Fitting and Ultrasound The subjects will be outfitted with the device by a&#xD;
      staff member appropriately trained in fitting the device in the proper location.&#xD;
&#xD;
      Station III: Wideband Absorbance and Oto-Acoustic Emissions This station will help determine&#xD;
      the effectiveness of the device by measuring the auditory response of a clicking noise that&#xD;
      will be non-invasively imparted into the subject's outer ear. For both tests, a soft silicone&#xD;
      tip is placed into the outer ear, and sounds are delivered via a miniature speaker. For the&#xD;
      wideband absorbance test, absorbed acoustic responses will be monitored to provide&#xD;
      information on the operation of the collar device. These are measured as changes in the&#xD;
      acoustic absorbance of the ear. For the oto-acoustic emission test, tones or clicks will be&#xD;
      presented to the ear with the same soft ear probe and recording microphones pick up the&#xD;
      oto-acoustic emission coming back from the outer hair cells of the inner ear. The computer&#xD;
      averages and processes the responses in reference to a noise floor across a specified&#xD;
      frequency range, displaying the results on the computer screen for the tester. The&#xD;
      oto-acoustic emissions test also provides a brief hearing screening to determine if hearing&#xD;
      is normal.&#xD;
&#xD;
      Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with&#xD;
      increased intracranial pressure, thus this simple, non-invasive exam will provide feedback on&#xD;
      the effectiveness of the device.&#xD;
&#xD;
      During the wideband absorbance and oto-acoustic emissions testing the study participants will&#xD;
      also be fitted with a compressive circumferential neck collar which can provide variable and&#xD;
      specific levels of pressure. The pressure is achieved by inflatable pods that sit adjacent to&#xD;
      the trachea affixed to a non-stretch adjustable collar. Manual inflation is regulated and&#xD;
      monitored by an experience operator/ technician through a bulb style pump and an electronic&#xD;
      gauge. Testing will occur without pressure and then with pressures applied up to 40mmHg.&#xD;
&#xD;
      Station IV: Hearing Assessment Otoscopy will be performed by an audiologist to note any ear&#xD;
      blockages, such as wax or drainage for exclusion purposes. The oto-acoustic emissions test&#xD;
      will be interpreted to determine if normal responses were obtained in each ear. If abnormal,&#xD;
      a hearing screening using pure tone audiometry screening will be provided free of charge. In&#xD;
      the event that the hearing screening is determined to be abnormal, the subject will receive&#xD;
      the results which may be shared with their primary care provider to determine any need for&#xD;
      referral for follow-up. If a subject is seen for follow-up at CCHMC following an abnormal&#xD;
      hearing assessment, this visit and any follow up visits will not be paid for by this project&#xD;
      and will be subject to insurance billing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Number of Participants Undergoing Acoustic Reflectance</measure>
    <time_frame>within single day</time_frame>
    <description>Number of participants undergoing acoustic reflectance with and without the compression collar</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">410</enrollment>
  <condition>Concussion</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Device wearing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects who meet the study criteria and volunteer to participate will be included in the study. Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device. The intervention will be the auto-acoustic measurement - taken while wearing the collar and then again when not wearing the collar.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device Wearing</intervention_name>
    <description>Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Each subject will undergo repeat oto-acoustic measures both wearing the device and not wearing the device</description>
    <arm_group_label>Device wearing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Normal healthy volunteer&#xD;
&#xD;
               -  Able to provide written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Unable to provide written consent&#xD;
&#xD;
               -  History of neurological deficits, previous cerebral infarction, or head trauma&#xD;
&#xD;
               -  Hydrocephalus&#xD;
&#xD;
               -  Known carotid hypersensitivity&#xD;
&#xD;
               -  Known increased intracranial pressure&#xD;
&#xD;
               -  Central vein thrombosis&#xD;
&#xD;
               -  Active concussion symptoms&#xD;
&#xD;
               -  Ventricular shunt or neurologic condition&#xD;
&#xD;
               -  Internal or external hardware that has been surgically placed in the neck&#xD;
&#xD;
               -  Any altered level of consciousness&#xD;
&#xD;
               -  Inability to sit still for 10 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>65 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>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>August 13, 2015</results_first_submitted>
  <results_first_submitted_qc>November 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 9, 2020</results_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain</keyword>
  <keyword>Hearing</keyword>
  <keyword>MTBI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data will be shared</ipd_description>
  </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>October 7, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02262507/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>September 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02262507/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Device Wearing</title>
          <description>All subjects who meet the study criteria and volunteer to participate will be included in the study.&#xD;
Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="410"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="410"/>
              </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>Device Wearing</title>
          <description>All subjects who meet the study criteria and volunteer to participate will be included in the study.&#xD;
Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="410"/>
          </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="335"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.5" lower_limit="12" upper_limit="65"/>
                  </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="251"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="159"/>
                  </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="410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Undergoing Acoustic Reflectance</title>
        <description>Number of participants undergoing acoustic reflectance with and without the compression collar</description>
        <time_frame>within single day</time_frame>
        <population>Subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Device Wearing</title>
            <description>All subjects who meet the study criteria and volunteer to participate will be included in the study.&#xD;
Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device.</description>
          </group>
          <group group_id="O2">
            <title>Non Device Wearing</title>
            <description>same subjects tested while not wearing the device</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Undergoing Acoustic Reflectance</title>
          <description>Number of participants undergoing acoustic reflectance with and without the compression collar</description>
          <population>Subjects</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="410"/>
                <count group_id="O2" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410"/>
                    <measurement group_id="O2" value="410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Device Wearing</title>
          <description>All subjects who meet the study criteria and volunteer to participate will be included in the study.&#xD;
Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="410"/>
              </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="410"/>
              </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>Dr. Gregory Myer</name_or_title>
      <organization>Cincinnati Childrens Hospital Sports Medicine</organization>
      <phone>513-636-0249</phone>
      <email>greg.myer@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/NCT02262507
org study id: 2013-5717
nct id: NCT02262507
lead sponsor: 
has dmc: Yes
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 that applies mild jugular compression according to
      the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC
      (Q30). Initial research suggests that the Device has the potential to reduce the likelihood
      of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is
      that the investigators need a physiologic, non-invasive method to evaluate the brain
      responses to mild jugular compression across multiple age groups. To determine this with MR
      imaging is currently cost prohibitive. The investigators pilot data from the parent IRB
      indicates a consistent response measured via wideband absorbance in young adults. Therefore,
      a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ
      this technology across a wide range of ages.
For the testing sessions, subjects may either come to our testing site or the investigators
      may bring the testing to their location (e.g. schools, work). The subjects will be fitted
      with a device around your neck, like a neck tie. The Device incorporates two bulges localized
      over the site of the internal jugular veins bilaterally. Experiments performed with jugular
      Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins
      are reduced, while flow within the carotid arteries and all portions of the cerebrum are
      preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will
      not cause any untoward health risks (IRB# 2013-2240 safety testing performed on this Device).
      The pressure exerted by the Device on the region of the neck superficial to the internal
      jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting
      necktie. The methods are utilized in prior approved IRB (2013-2240)..

      Station I: Consent to Participate Each participant will review the Institutional Review Board
      approved consent to participate form prior to data collection. They will be given an adequate
      amount of time to ask questions to the study coordinator, or the person obtaining consent,
      and then make their decision to participate or not participate. If they wish to participate,
      they will be asked to sign the informed consent form. For middle school and high school
      subjects recruited via the investigators relationship with the schools, this station will be
      designated to review consent and assent forms to ensure that proper signatures have been
      obtained.

      Station II: Device Fitting and Ultrasound The subjects will be outfitted with the device by a
      staff member appropriately trained in fitting the device in the proper location.

      Station III: Wideband Absorbance and Oto-Acoustic Emissions This station will help determine
      the effectiveness of the device by measuring the auditory response of a clicking noise that
      will be non-invasively imparted into the subject's outer ear. For both tests, a soft silicone
      tip is placed into the outer ear, and sounds are delivered via a miniature speaker. For the
      wideband absorbance test, absorbed acoustic responses will be monitored to provide
      information on the operation of the collar device. These are measured as changes in the
      acoustic absorbance of the ear. For the oto-acoustic emission test, tones or clicks will be
      presented to the ear with the same soft ear probe and recording microphones pick up the
      oto-acoustic emission coming back from the outer hair cells of the inner ear. The computer
      averages and processes the responses in reference to a noise floor across a specified
      frequency range, displaying the results on the computer screen for the tester. The
      oto-acoustic emissions test also provides a brief hearing screening to determine if hearing
      is normal.

      Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with
      increased intracranial pressure, thus this simple, non-invasive exam will provide feedback on
      the effectiveness of the device.

      During the wideband absorbance and oto-acoustic emissions testing the study participants will
      also be fitted with a compressive circumferential neck collar which can provide variable and
      specific levels of pressure. The pressure is achieved by inflatable pods that sit adjacent to
      the trachea affixed to a non-stretch adjustable collar. Manual inflation is regulated and
      monitored by an experience operator/ technician through a bulb style pump and an electronic
      gauge. Testing will occur without pressure and then with pressures applied up to 40mmHg.

      Station IV: Hearing Assessment Otoscopy will be performed by an audiologist to note any ear
      blockages, such as wax or drainage for exclusion purposes. The oto-acoustic emissions test
      will be interpreted to determine if normal responses were obtained in each ear. If abnormal,
      a hearing screening using pure tone audiometry screening will be provided free of charge. In
      the event that the hearing screening is determined to be abnormal, the subject will receive
      the results which may be shared with their primary care provider to determine any need for
      referral for follow-up. If a subject is seen for follow-up at CCHMC following an abnormal
      hearing assessment, this visit and any follow up visits will not be paid for by this project
      and will be subject to insurance billing.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants Undergoing Acoustic Reflectance
time frame: within single day
description: Number of participants undergoing acoustic reflectance with and without the compression collar
arm group label: Device wearing
arm group type: Experimental
description: All subjects who meet the study criteria and volunteer to participate will be included in the study. Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device. The intervention will be the auto-acoustic measurement - taken while wearing the collar and then again when not wearing the collar.
intervention type: Device
intervention name: Device Wearing
description: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Each subject will undergo repeat oto-acoustic measures both wearing the device and not wearing the device
arm group label: Device wearing
criteria: 
gender: All
minimum age: 8 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: No
ipd description: No individual participant data will be shared
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 