<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/NCT03231254</url>
  </required_header>
  <id_info>
    <org_study_id>AF-SOP-07-1.0-01</org_study_id>
    <nct_id>NCT03231254</nct_id>
  </id_info>
  <brief_title>Differences in Predicted Therapeutic Outcome of Oral Appliance Determined by RCMP in Quebec Versus Shenyang Patients With OSA.</brief_title>
  <acronym>RCMP</acronym>
  <official_title>Differences in Predicted Therapeutic Outcome of Oral Appliance and Optimal Protrusion Position Determined by Remotely Controlled Mandibular Positioner (RCMP) With Overnight PSG in Quebec Versus Shenyang Patients With OSA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Hospital of China Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Objective: To explore the differences in predicted therapeutic outcome of OA and&#xD;
      optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP)&#xD;
      with overnight PSG in Quebec versus Shenyang patients with OSA.&#xD;
&#xD;
      Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder&#xD;
      clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests&#xD;
      performed in sleep laboratory.&#xD;
&#xD;
      Participants: Consecutive specific OSA patients, who are potential candidates for treatment&#xD;
      of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a&#xD;
      sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with&#xD;
      broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI&lt;40 kg/m2).&#xD;
&#xD;
      Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only&#xD;
      predicts the eventual therapeutic outcome but also prospectively determines Optimal&#xD;
      Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA&#xD;
      therapy. One goal of this study is to identify OA favorable candidates by physicians using&#xD;
      prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome&#xD;
      of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be&#xD;
      processed after matching for OSA severity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">October 29, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The differences of predicted therapeutic outcome of OA between two groups.</measure>
    <time_frame>2017.7-2017.11</time_frame>
    <description>To identify and compare the number of OA favorable candidates by physicians using prospectively and explicitly designed criteria in both groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The differences of optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.</measure>
    <time_frame>2017.7-2017.11</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Remotely Controlled Mandibular Positioner</condition>
  <arm_group>
    <arm_group_label>Chinese patients with OSA</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Canada patients with OSA</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remotely Controlled Mandibular Positioner (RCMP)</intervention_name>
    <description>RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep.</description>
    <arm_group_label>Canada patients with OSA</arm_group_label>
    <arm_group_label>Chinese patients with OSA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Research participants will be respectively recruited from Sleep Centre of IOCPQ of Laval&#xD;
        (Quebec, Canada) and CMU first affiliated hospital (Shenyang, China), which receives the&#xD;
        majority of referrals from respirologists, psychiatrists, otolaryngologists and dentists&#xD;
        practicing in Quebec and Shenyang City. Consecutive patients between 20 and 75 years of&#xD;
        age, satisfying the pre-mentioned inclusion will be considered eligible to our study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recent diagnosis of OSAS (AHI&gt;15/h) announced by a sleep recording; mean oxygen&#xD;
             saturation &gt;90%; mandibular range of motion &gt;5 mm; adequate dentition: ≥10 upper and&#xD;
             10 lower teeth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1). Body mass index 40 kg/m2 or greater; (2).Inability to tolerate overnight&#xD;
             polysomnography in sleep lab; (3).&gt;50% of observed sleep apneas being central; (4).&#xD;
             Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic&#xD;
             limb movement disorder or restless legs syndrome; (5). Those with severe pharyngeal&#xD;
             obstruction on physical exam (pharyngeal grade more than II); (6).severe nasal&#xD;
             obstruction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Hospital of China Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frederic Series, master</last_name>
    <role>Study Director</role>
    <affiliation>Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frederic Series</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenyang Li</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013 Oct 1;36(10):1517-25, 1525A. doi: 10.5665/sleep.3048.</citation>
    <PMID>24082311</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Hospital of China Medical University</investigator_affiliation>
    <investigator_full_name>Wenyang Li</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03231254
org study id: AF-SOP-07-1.0-01
nct id: NCT03231254
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Study Objective: To explore the differences in predicted therapeutic outcome of OA and
      optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP)
      with overnight PSG in Quebec versus Shenyang patients with OSA.

      Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder
      clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests
      performed in sleep laboratory.

      Participants: Consecutive specific OSA patients, who are potential candidates for treatment
      of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a
      sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with
      broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2).

      Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only
      predicts the eventual therapeutic outcome but also prospectively determines Optimal
      Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA
      therapy. One goal of this study is to identify OA favorable candidates by physicians using
      prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome
      of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be
      processed after matching for OSA severity.
observational model: Case-Only
time perspective: Cross-Sectional
measure: The differences of predicted therapeutic outcome of OA between two groups.
time frame: 2017.7-2017.11
description: To identify and compare the number of OA favorable candidates by physicians using prospectively and explicitly designed criteria in both groups.
measure: The differences of optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.
time frame: 2017.7-2017.11
arm group label: Chinese patients with OSA
arm group label: Canada patients with OSA
intervention type: Device
intervention name: Remotely Controlled Mandibular Positioner (RCMP)
description: RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep.
arm group label: Canada patients with OSA
arm group label: Chinese patients with OSA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wei Wang, PhD
role: Principal Investigator
affiliation: First Hospital of China Medical University
last name: Frederic Series, master
role: Study Director
affiliation: Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec
facility: 
facility: 
country: Canada
country: China
citation: Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013 Oct 1;36(10):1517-25, 1525A. doi: 10.5665/sleep.3048.
PMID: 24082311
responsible party type: Principal Investigator
investigator affiliation: First Hospital of China Medical University
investigator full name: Wenyang Li
investigator title: Medical doctor
sharing ipd: Undecided