<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/NCT03004014</url>
  </required_header>
  <id_info>
    <org_study_id>13900</org_study_id>
    <nct_id>NCT03004014</nct_id>
  </id_info>
  <brief_title>Natural Sleep and Drug-induced Sleep Endoscopy</brief_title>
  <official_title>Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pedro Rodrigues Genta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the&#xD;
      site and configuration of upper airway obstruction in patients with obstructive sleep apnea&#xD;
      (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep.&#xD;
      Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical&#xD;
      treatment.&#xD;
&#xD;
      Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be&#xD;
      enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the&#xD;
      night. Propofol induced sleep will be performed at the operating room before surgery. The&#xD;
      VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be&#xD;
      used to compare site and configuration of collapse between studies. Peak inspiratory flow&#xD;
      will also be compared between studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the&#xD;
      site and configuration of upper airway obstruction in patients with obstructive sleep apnea.&#xD;
      However, there are no studies comparing DISE to sleep endoscopy during natural sleep.&#xD;
      Objective: to compare natural sleep endoscopy to drug induced sleep with propofol.&#xD;
&#xD;
      The study population will include 28 patients who are candidates to surgical treatment.&#xD;
&#xD;
      Methods Detailed clinical history and physical examination will be performed before natural&#xD;
      sleep endoscopy. A 2-hour fast will be required. During both natural sleep and&#xD;
      propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter&#xD;
      (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and&#xD;
      oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and&#xD;
      placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm&#xD;
      pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril.&#xD;
      A nasal mask will be fitted and a heated pneumotachograph with differential pressure&#xD;
      transducer connected to the mask will quantify airflow. The endoscope will be located at&#xD;
      velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE&#xD;
      Endoscopic Classification will be used to describe site and configuration of pharyngeal&#xD;
      collapse in each study. The study will be scored by two experienced investigators, blind to&#xD;
      the patient identification and type of study (natural sleep or drug-induced).&#xD;
      Propofol-induced sleep will be performed at the operating room before surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The VOTE Endoscopic Classification</measure>
    <time_frame>Immediately, during the procedure</time_frame>
    <description>Comparison of site and configuration of endoscopy findings between the natural and drug-induced sleep endoscopy. The VOTE Endoscopic Classification describes the patterns and the degree of obstruction during sleep endoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak inspiratory flow</measure>
    <time_frame>Immediately, during the procedure</time_frame>
    <description>Peak inspiratory flow measured during both natural and drug-induced sleep endoscopy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Natural Sleep</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol Induced Sleep</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sleep endoscopy during propofol induced sleep&#xD;
OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep endoscopy during propofol induced sleep</intervention_name>
    <description>It will be performed a sleep endoscopy during drug induced sleep endoscopy</description>
    <arm_group_label>Propofol Induced Sleep</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI less than 35kg/m2&#xD;
&#xD;
          -  Apnea-hypopnea index &gt; 5 events/hour of sleep&#xD;
&#xD;
          -  Clinical indication of surgical treatment for sleep apnea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe or decompensated cardiac or respiratory diseases&#xD;
&#xD;
          -  Previous pharyngeal surgery&#xD;
&#xD;
          -  Tonsils grade III or IV&#xD;
&#xD;
          -  Other sleep disturbance (parasomnias, primary insomnia, narcolepsy)&#xD;
&#xD;
          -  Sedative medication use (opioids, benzodiazepines and muscle relaxants)&#xD;
&#xD;
          -  Uncontrolled diabetes or hyperthyroidism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedro R Genta, Post Doc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sleep Laboratoy, Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>July 29, 2018</last_update_submitted>
  <last_update_submitted_qc>July 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Pedro Rodrigues Genta</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sleep endoscopy</keyword>
  <keyword>sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03004014
org study id: 13900
nct id: NCT03004014
lead sponsor: 
has dmc: Yes
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the
      site and configuration of upper airway obstruction in patients with obstructive sleep apnea
      (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep.
      Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical
      treatment.

      Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be
      enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the
      night. Propofol induced sleep will be performed at the operating room before surgery. The
      VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be
      used to compare site and configuration of collapse between studies. Peak inspiratory flow
      will also be compared between studies.
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the
      site and configuration of upper airway obstruction in patients with obstructive sleep apnea.
      However, there are no studies comparing DISE to sleep endoscopy during natural sleep.
      Objective: to compare natural sleep endoscopy to drug induced sleep with propofol.

      The study population will include 28 patients who are candidates to surgical treatment.

      Methods Detailed clinical history and physical examination will be performed before natural
      sleep endoscopy. A 2-hour fast will be required. During both natural sleep and
      propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter
      (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and
      oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and
      placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm
      pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril.
      A nasal mask will be fitted and a heated pneumotachograph with differential pressure
      transducer connected to the mask will quantify airflow. The endoscope will be located at
      velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE
      Endoscopic Classification will be used to describe site and configuration of pharyngeal
      collapse in each study. The study will be scored by two experienced investigators, blind to
      the patient identification and type of study (natural sleep or drug-induced).
      Propofol-induced sleep will be performed at the operating room before surgery.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: The VOTE Endoscopic Classification
time frame: Immediately, during the procedure
description: Comparison of site and configuration of endoscopy findings between the natural and drug-induced sleep endoscopy. The VOTE Endoscopic Classification describes the patterns and the degree of obstruction during sleep endoscopy.
measure: Peak inspiratory flow
time frame: Immediately, during the procedure
description: Peak inspiratory flow measured during both natural and drug-induced sleep endoscopy
arm group label: Natural Sleep
arm group type: No Intervention
description: OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep
arm group label: Propofol Induced Sleep
arm group type: Other
description: Sleep endoscopy during propofol induced sleep
OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep
intervention type: Other
intervention name: Sleep endoscopy during propofol induced sleep
description: It will be performed a sleep endoscopy during drug induced sleep endoscopy
arm group label: Propofol Induced Sleep
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pedro R Genta, Post Doc
role: Principal Investigator
affiliation: Sleep Laboratoy, Heart Institute
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Pedro Rodrigues Genta
investigator title: Principal Investigator
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Propofol
sharing ipd: Yes