<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/NCT03285451</url>
  </required_header>
  <id_info>
    <org_study_id>06-X07-017</org_study_id>
    <nct_id>NCT03285451</nct_id>
  </id_info>
  <brief_title>Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients</brief_title>
  <official_title>Correlative Analysis of Upper Airway Collapse in Sleep Endoscope and Submental Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, submental ultrasound during awake and simultaneous under Drug-induced sleep&#xD;
      endoscopy is applied in the diagnostic workup of obstructive sleep apnea patients. The aim is&#xD;
      to assess the tongue base thickness during awake and sleep with different head positions. By&#xD;
      correlation with Drug-induced sleep endoscopy findings, more parameters could be used for&#xD;
      evaluation and management of upper airway collapse in obstructive sleep apnea patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is a syndrome characterized by recurrent episodes of apnea and&#xD;
      hypopnea during sleep that are caused by repetitive upper airway (UA) collapse and often&#xD;
      result in decreased blood oxygen levels and arousal from sleep. Successful treatment lies in&#xD;
      precise mapping the site of airway narrowing.&#xD;
&#xD;
      Drug-induced sleep endoscopy (DISE) is a well described modality to mimic the dynamic change&#xD;
      of UA in OSA patients during natural sleep. Nevertheless, the tongue base thickness (TBT),&#xD;
      one of the important anatomic factors in OSA, is hard to evaluate under this method.&#xD;
      Recently, submental ultrasound (US), the noninvasive and convenient tool, has been widely&#xD;
      applied to measure the TBT in awake OSA patients, so as to predict the severity and&#xD;
      relationship with UA collapse. However, few evidence has addressed the relationship between&#xD;
      UA collapse and the TBT in different head positions, awake and sleep period In this study,&#xD;
      submental US during awake and drug induced sleep period is applied in the diagnostic workup&#xD;
      of OSA patients. By correlation with DISE findings, more parameters could be used for&#xD;
      evaluation and management of upper airway collapse in OSA patients.&#xD;
&#xD;
      Key Words: Submental ultrasound, Obstructive sleep apnea, Drug-induced sleep endoscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 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>The value of drug induced sleep ultrasonography in patients with obstructive sleep apnea</measure>
    <time_frame>May, 2017 to Aug, 2017</time_frame>
    <description>In this study, we proposed a novel method, drug induced sleep ultrasonography (DISU), which was applied to measure the tongue base thickness in OSA patients during drug induced sleep, so as to further understand the impact of dynamic change of tongue base thickness in OSA patients.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>submental ultrasonography</intervention_name>
    <description>Submental ultrasound, the noninvasive and convenient tool, has been widely applied to measure the tongue base thickness in patients with obstructive sleep apnea, so as to predict the severity and relationship with upper airway collapse.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Obstructive sleep apnea patients, age between 20-70 without severe heart, lung, liver, and&#xD;
        kidney comorbidity or propofol or dexmedetomidine allergies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obstructive sleep apnea patients, age between 20-70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe heart, lung, liver, and kidney comorbidity propofol or dexmedetomidine&#xD;
             allergies (albeit rare)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Chin Lan, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Taipei Tzu Chi Hospita l Buddhist Tzu Chi Medical Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Chin Lan, MD</last_name>
    <phone>+886920734552</phone>
    <email>lanmingchin@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation</name>
      <address>
        <city>Taipei</city>
        <zip>231</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Chin Lan, MD</last_name>
      <phone>+886920734552</phone>
      <email>lanmingchin@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Submental ultrasound, Obstructive sleep apnea</keyword>
  <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>
  <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/NCT03285451
org study id: 06-X07-017
nct id: NCT03285451
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this study, submental ultrasound during awake and simultaneous under Drug-induced sleep
      endoscopy is applied in the diagnostic workup of obstructive sleep apnea patients. The aim is
      to assess the tongue base thickness during awake and sleep with different head positions. By
      correlation with Drug-induced sleep endoscopy findings, more parameters could be used for
      evaluation and management of upper airway collapse in obstructive sleep apnea patients.
Obstructive sleep apnea (OSA) is a syndrome characterized by recurrent episodes of apnea and
      hypopnea during sleep that are caused by repetitive upper airway (UA) collapse and often
      result in decreased blood oxygen levels and arousal from sleep. Successful treatment lies in
      precise mapping the site of airway narrowing.

      Drug-induced sleep endoscopy (DISE) is a well described modality to mimic the dynamic change
      of UA in OSA patients during natural sleep. Nevertheless, the tongue base thickness (TBT),
      one of the important anatomic factors in OSA, is hard to evaluate under this method.
      Recently, submental ultrasound (US), the noninvasive and convenient tool, has been widely
      applied to measure the TBT in awake OSA patients, so as to predict the severity and
      relationship with UA collapse. However, few evidence has addressed the relationship between
      UA collapse and the TBT in different head positions, awake and sleep period In this study,
      submental US during awake and drug induced sleep period is applied in the diagnostic workup
      of OSA patients. By correlation with DISE findings, more parameters could be used for
      evaluation and management of upper airway collapse in OSA patients.

      Key Words: Submental ultrasound, Obstructive sleep apnea, Drug-induced sleep endoscopy
observational model: Other
time perspective: Prospective
measure: The value of drug induced sleep ultrasonography in patients with obstructive sleep apnea
time frame: May, 2017 to Aug, 2017
description: In this study, we proposed a novel method, drug induced sleep ultrasonography (DISU), which was applied to measure the tongue base thickness in OSA patients during drug induced sleep, so as to further understand the impact of dynamic change of tongue base thickness in OSA patients.
intervention type: Diagnostic Test
intervention name: submental ultrasonography
description: Submental ultrasound, the noninvasive and convenient tool, has been widely applied to measure the tongue base thickness in patients with obstructive sleep apnea, so as to predict the severity and relationship with upper airway collapse.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ming-Chin Lan, MD
role: Study Chair
affiliation: Taipei Tzu Chi Hospita l Buddhist Tzu Chi Medical Foundation
last name: Ming-Chin Lan, MD
phone: +886920734552
email: lanmingchin@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No