<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/NCT03812692</url>
  </required_header>
  <id_info>
    <org_study_id>ZCP201901</org_study_id>
    <nct_id>NCT03812692</nct_id>
  </id_info>
  <brief_title>Validation of a Simplified MATRx Plus</brief_title>
  <official_title>Validation of a Simplified MATRx Plus Theragnostic Sleep Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zephyr Sleep Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zephyr Sleep Technologies</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly&#xD;
      closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep&#xD;
      apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients.&#xD;
      Another treatment is to use an oral appliance in your mouth when you sleep. The appliance&#xD;
      covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat&#xD;
      passage and allowing normal breathing.&#xD;
&#xD;
      Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to&#xD;
      identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has&#xD;
      invented a feedback-controlled device that tests various positions of the lower jaw. This&#xD;
      commercially available device, known as MATRx plus, is a Health Canada approved and FDA&#xD;
      cleared motorized dental positioner that can be used in an overnight sleep study performed in&#xD;
      the home. Temporary dental impression trays cover your upper and lower teeth. These are&#xD;
      attached to a small motor that slowly and gently pulls your lower jaw forward under the&#xD;
      control of a computer in response to real-time breathing events. The commercial MATRx plus&#xD;
      device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse&#xD;
      oximeter to guide the movement of the lower jaw during the test. Though the test is accurate,&#xD;
      the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a&#xD;
      simplified version of the test that requires fewer sensors and sleep time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly&#xD;
      closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep&#xD;
      apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients.&#xD;
      Another treatment is to use an oral appliance in your mouth when you sleep. The appliance&#xD;
      covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat&#xD;
      passage and allowing normal breathing.&#xD;
&#xD;
      Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to&#xD;
      identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has&#xD;
      invented a feedback-controlled device that tests various positions of the lower jaw. This&#xD;
      commercially available device, known as MATRx plus, is a Health Canada approved and FDA&#xD;
      cleared motorized dental positioner that can be used in an overnight sleep study performed in&#xD;
      the home. Temporary dental impression trays cover your upper and lower teeth. These are&#xD;
      attached to a small motor that slowly and gently pulls your lower jaw forward under the&#xD;
      control of a computer in response to real-time breathing events. The commercial MATRx plus&#xD;
      device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse&#xD;
      oximeter to guide the movement of the lower jaw during the test. Though the test is accurate,&#xD;
      the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a&#xD;
      simplified version of the test that requires fewer sensors and sleep time.&#xD;
&#xD;
      We have previously carried out three research studies leading to the development of the&#xD;
      feedback-controlled mandibular positioner. These studies, two of which used early prototypes&#xD;
      of the device and one that used the commercial MATRx plus device, showed that the&#xD;
      feedback-control software used was very accurate and was able to identify successful&#xD;
      candidates in a home setting.&#xD;
&#xD;
      No serious or permanent problems or risks were identified in any of the previous research&#xD;
      studies. Participants reported minor tooth and gum discomfort on the morning following the&#xD;
      test and other minor issues including dry mouth, excessive saliva, and being unable to sleep.&#xD;
      The previous studies have established the safety and efficacy of the device using a device&#xD;
      prototype. The purpose of the present study is to determine if the efficacy of the device is&#xD;
      maintained when fewer sensors are used and the requirement for sleep time is reduced.&#xD;
&#xD;
      The study will collect data over one night in a sleep laboratory and a series of nights in&#xD;
      the home. Following the study, you will be told if you are a suitable candidate for oral&#xD;
      appliance therapy. If you do not already have a custom oral appliance, one will be provided&#xD;
      to you. During the study, the Principal Investigator and study dentist will be blinded to the&#xD;
      results of your tests. In the event of an emergency, the Principal Investigator can be&#xD;
      unblinded to your test results.&#xD;
&#xD;
      Up to 46 individuals will be recruited for this study. Study participants will need to attend&#xD;
      visits at multiple centres located in Calgary, Alberta.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen desaturation index</measure>
    <time_frame>6 weeks</time_frame>
    <description>With the oral appliance in place, participants will complete a 2-night home sleep apnea test with a Level III sleep recorder. The participant's oxygen desaturation index with the appliance will be recorded.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>MATRx plus test</arm_group_label>
    <description>All participants will complete the MATRx plus test unattended in the home. Not all participants will be predicted responders to oral appliance therapy; both predicted responders and non-responders will undergo an outcome home sleep apnea test with a custom oral appliance in place to validate the prediction made by the test. Twenty participants will also complete an in-lab sleep study prior to the home study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MATRx plus</intervention_name>
    <description>The MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective.</description>
    <arm_group_label>MATRx plus test</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be representative of the general population of individuals with&#xD;
        obstructive sleep apnea in North America.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged between 21 and 80 years&#xD;
&#xD;
          2. Obstructive sleep apnea (ODI &gt; 10 h-1)&#xD;
&#xD;
          3. Body mass index &lt; 45 kg/m2&#xD;
&#xD;
          4. Neck circumference &lt; 50 cm&#xD;
&#xD;
          5. Absence of severe oxyhemoglobin desaturation during sleep, indicated by a mean value&#xD;
             of oxyhemoglobin saturation (SaO2) &gt; 87%&#xD;
&#xD;
          6. Mandibular range of motion &gt; 5 mm&#xD;
&#xD;
          7. Adequate dentition (10 upper and 10 lower teeth)&#xD;
&#xD;
          8. Ability to understand and provide informed consent&#xD;
&#xD;
          9. Ability and willingness to meet the required schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to breathe comfortably through the nose&#xD;
&#xD;
          2. Central Sleep Apnea (&gt; 50% of apneas are central)&#xD;
&#xD;
          3. Anticipated change in medical therapy that could alter the severity of OSA during the&#xD;
             protocol&#xD;
&#xD;
          4. Anticipated change in body weight (5% or more) during the protocol&#xD;
&#xD;
          5. Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic&#xD;
             insomnia&#xD;
&#xD;
          6. Severe respiratory disorder(s) other than sleep disordered breathing&#xD;
&#xD;
          7. Loose teeth, faulty restorations, or advanced periodontal disease&#xD;
&#xD;
          8. Participation in other studies that could interfere with study protocol&#xD;
&#xD;
          9. Pregnant or nursing&#xD;
&#xD;
         10. Heart failure&#xD;
&#xD;
         11. Cerebral vascular incident within the last 12 months&#xD;
&#xD;
         12. Use of pacemaker or other life supporting device&#xD;
&#xD;
         13. Regular use of CPAP or oral appliance therapy within 5 days of the PSG or HSAT&#xD;
             (individuals on therapy wishing to participate may opt to cease therapy for the 5&#xD;
             nights prior to each test)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zephyr Sleep Technologies</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2H-2C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral appliance therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03812692
org study id: ZCP201901
nct id: NCT03812692
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly
      closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep
      apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients.
      Another treatment is to use an oral appliance in your mouth when you sleep. The appliance
      covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat
      passage and allowing normal breathing.

      Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to
      identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has
      invented a feedback-controlled device that tests various positions of the lower jaw. This
      commercially available device, known as MATRx plus, is a Health Canada approved and FDA
      cleared motorized dental positioner that can be used in an overnight sleep study performed in
      the home. Temporary dental impression trays cover your upper and lower teeth. These are
      attached to a small motor that slowly and gently pulls your lower jaw forward under the
      control of a computer in response to real-time breathing events. The commercial MATRx plus
      device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse
      oximeter to guide the movement of the lower jaw during the test. Though the test is accurate,
      the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a
      simplified version of the test that requires fewer sensors and sleep time.
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly
      closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep
      apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients.
      Another treatment is to use an oral appliance in your mouth when you sleep. The appliance
      covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat
      passage and allowing normal breathing.

      Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to
      identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has
      invented a feedback-controlled device that tests various positions of the lower jaw. This
      commercially available device, known as MATRx plus, is a Health Canada approved and FDA
      cleared motorized dental positioner that can be used in an overnight sleep study performed in
      the home. Temporary dental impression trays cover your upper and lower teeth. These are
      attached to a small motor that slowly and gently pulls your lower jaw forward under the
      control of a computer in response to real-time breathing events. The commercial MATRx plus
      device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse
      oximeter to guide the movement of the lower jaw during the test. Though the test is accurate,
      the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a
      simplified version of the test that requires fewer sensors and sleep time.

      We have previously carried out three research studies leading to the development of the
      feedback-controlled mandibular positioner. These studies, two of which used early prototypes
      of the device and one that used the commercial MATRx plus device, showed that the
      feedback-control software used was very accurate and was able to identify successful
      candidates in a home setting.

      No serious or permanent problems or risks were identified in any of the previous research
      studies. Participants reported minor tooth and gum discomfort on the morning following the
      test and other minor issues including dry mouth, excessive saliva, and being unable to sleep.
      The previous studies have established the safety and efficacy of the device using a device
      prototype. The purpose of the present study is to determine if the efficacy of the device is
      maintained when fewer sensors are used and the requirement for sleep time is reduced.

      The study will collect data over one night in a sleep laboratory and a series of nights in
      the home. Following the study, you will be told if you are a suitable candidate for oral
      appliance therapy. If you do not already have a custom oral appliance, one will be provided
      to you. During the study, the Principal Investigator and study dentist will be blinded to the
      results of your tests. In the event of an emergency, the Principal Investigator can be
      unblinded to your test results.

      Up to 46 individuals will be recruited for this study. Study participants will need to attend
      visits at multiple centres located in Calgary, Alberta.
observational model: Other
time perspective: Prospective
measure: Oxygen desaturation index
time frame: 6 weeks
description: With the oral appliance in place, participants will complete a 2-night home sleep apnea test with a Level III sleep recorder. The participant's oxygen desaturation index with the appliance will be recorded.
arm group label: MATRx plus test
description: All participants will complete the MATRx plus test unattended in the home. Not all participants will be predicted responders to oral appliance therapy; both predicted responders and non-responders will undergo an outcome home sleep apnea test with a custom oral appliance in place to validate the prediction made by the test. Twenty participants will also complete an in-lab sleep study prior to the home study.
intervention type: Device
intervention name: MATRx plus
description: The MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective.
arm group label: MATRx plus test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: No