<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/NCT01683721</url>
  </required_header>
  <id_info>
    <org_study_id>12023</org_study_id>
    <nct_id>NCT01683721</nct_id>
  </id_info>
  <brief_title>Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)</brief_title>
  <acronym>UNMASK</acronym>
  <official_title>The UNMASK Study: A Post-Market Longitudinal Observational Study of the WinxTM Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ApniCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ApniCure, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System&#xD;
      in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Winx</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with obstructive sleep apnea (OSA)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria&#xD;
&#xD;
          -  Has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.&#xD;
&#xD;
          -  Has loose teeth or advanced periodontal disease.&#xD;
&#xD;
          -  Is under the age of 18.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lawrence Siegel, MD</last_name>
    <phone>650-361-9399</phone>
    <email>lsiegel@apnicure.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Petersburg Sleep Disorders Center</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33707</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>727-360-0853</phone>
    </contact>
    <investigator>
      <last_name>Neil T Feldman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sleep Medicine Associates of Texas (SMAT)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip Becker, MD</last_name>
      <phone>214-389-1740</phone>
    </contact>
    <investigator>
      <last_name>Philip Becker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 3, 2013</last_update_submitted>
  <last_update_submitted_qc>September 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2013</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>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT01683721
org study id: 12023
nct id: NCT01683721
lead sponsor: 
has dmc: No
The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System
      in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).
observational model: Cohort
time perspective: Prospective
arm group label: Winx
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lawrence Siegel, MD
phone: 650-361-9399
email: lsiegel@apnicure.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive