<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/NCT02257320</url>
  </required_header>
  <id_info>
    <org_study_id>TMJ-1002</org_study_id>
    <nct_id>NCT02257320</nct_id>
  </id_info>
  <brief_title>TMJ NextGeneration(TM) Feasibility Study</brief_title>
  <acronym>Bruxoff</acronym>
  <official_title>A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TMJ Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiox Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiox Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is an open-label, prospective, single-center, non-randomized feasibility study of&#xD;
      the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the&#xD;
      impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events&#xD;
      and incidence of migraines and headache in subjects diagnosed with sleep bruxism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted at one study center in the U.S. Subjects will be enrolled in the&#xD;
      trial for a period of 8 weeks. The study will consist of a screening phase lasting up to 2&#xD;
      weeks and a follow up treatment period lasting 8 weeks. Subjects will visit the dental clinic&#xD;
      twice during the screening period, then five times during the treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Bruxism</condition>
  <arm_group>
    <arm_group_label>Feasibility</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Assessing EMG activity with Bruxoff(TM) device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMJ NextGeneration(TM)</intervention_name>
    <description>The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the ear canal when the jaw is in the open position and permit full passage of sound into each ear. The mechanisms of action of the inserts are to support the TMJ and associated secondary musculature to reduce strain in the TMJ area and to provide cognitive awareness to the wearer regarding para-functional habits, i.e., jaw clenching.</description>
    <arm_group_label>Feasibility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects at least 18 years of age;&#xD;
&#xD;
          2. Subject has had a diagnosis of sleep bruxism;&#xD;
&#xD;
          3. Subject has been medically screened and diagnosed by a physician as having headaches&#xD;
             and/or migraines;&#xD;
&#xD;
          4. Subject is willing to comply with the usage instructions for the Bruxoff device;&#xD;
&#xD;
          5. Is able to read and understand the ICF and has voluntarily provided written informed&#xD;
             consent.&#xD;
&#xD;
          6. Subject is able to open their mouth at least 17 mm to be fitted for the TMJ&#xD;
             NextGenerationTM device;&#xD;
&#xD;
          7. Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff&#xD;
             device will be used;&#xD;
&#xD;
          8. Subject agrees that when using the Bruxoff device to keep their cellular phone in&#xD;
             another room.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with any physical or behavioral disorder, which, in the opinion of the&#xD;
             Principal Investigator, may interfere with the use of the device or compliance with&#xD;
             the study protocol;&#xD;
&#xD;
          2. Subject has any sleep disorder other than bruxism;&#xD;
&#xD;
          3. Subjects who have had direct trauma to the jaw;&#xD;
&#xD;
          4. Subjects who have had prior TMJ or ear surgery;&#xD;
&#xD;
          5. Subjects who have a narrow ear canal or impression of the ear canal, which is&#xD;
             prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a&#xD;
             canal that does not allow for the ear canal second turn to be identified;&#xD;
&#xD;
          6. Subjects with visible or congenital ear deformity as observed on targeted physical&#xD;
             exam;&#xD;
&#xD;
          7. Subjects whose ear canal anatomy does not allow for fit of the study device;&#xD;
&#xD;
          8. Subjects who have a history of ear pain unrelated to TMJ;&#xD;
&#xD;
          9. Subjects who have a history of ear drainage in the past 6 months;&#xD;
&#xD;
         10. Subjects who have active ear drainage, swelling, or redness as observed on targeted&#xD;
             physical exam;&#xD;
&#xD;
         11. Subject has experienced chronic pain (not including migraine pain) associated with&#xD;
             sleep bruxism or TMD for more than six months;&#xD;
&#xD;
         12. Subject has a pacemaker.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>simon blackburn</last_name>
    <role>Study Director</role>
    <affiliation>Cardiox Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ear, Nose and Throat Associates of South Florida</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ear, Nose and Throat Associates of South Florida</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>June 8, 2015</last_update_submitted>
  <last_update_submitted_qc>June 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</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>Bruxism</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02257320
org study id: TMJ-1002
nct id: NCT02257320
lead sponsor: 
collaborator: 
has dmc: No
The study is an open-label, prospective, single-center, non-randomized feasibility study of
      the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the
      impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events
      and incidence of migraines and headache in subjects diagnosed with sleep bruxism.
The study will be conducted at one study center in the U.S. Subjects will be enrolled in the
      trial for a period of 8 weeks. The study will consist of a screening phase lasting up to 2
      weeks and a follow up treatment period lasting 8 weeks. Subjects will visit the dental clinic
      twice during the screening period, then five times during the treatment period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.
time frame: baseline and 8 weeks
arm group label: Feasibility
arm group type: Other
description: Assessing EMG activity with Bruxoff(TM) device
intervention type: Device
intervention name: TMJ NextGeneration(TM)
description: The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the ear canal when the jaw is in the open position and permit full passage of sound into each ear. The mechanisms of action of the inserts are to support the TMJ and associated secondary musculature to reduce strain in the TMJ area and to provide cognitive awareness to the wearer regarding para-functional habits, i.e., jaw clenching.
arm group label: Feasibility
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: simon blackburn
role: Study Director
affiliation: Cardiox Corporation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bruxism