<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/NCT03770715</url>
  </required_header>
  <id_info>
    <org_study_id>1802051921</org_study_id>
    <nct_id>NCT03770715</nct_id>
  </id_info>
  <brief_title>Sleep Apnea After Extubation</brief_title>
  <official_title>Sleep Apnea After Extubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep apnea is common after extubation, approximately 71%, and is independently associated&#xD;
      with hypertension and metabolic disease contributing to increased morbidity and mortality.&#xD;
      Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the&#xD;
      management of more symptomatic patients with obstructive sleep apnea.&#xD;
&#xD;
      The aim of this study is to evaluate the prevalence of sleep apnea after extubation by&#xD;
      respiratory polygraphy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2018</start_date>
  <completion_date type="Actual">December 2, 2019</completion_date>
  <primary_completion_date type="Actual">May 24, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Prevalence of sleep apnea after exutbation</measure>
    <time_frame>during first to second night following extubation</time_frame>
  </primary_outcome>
  <enrollment type="Actual">13</enrollment>
  <condition>Sleep Apnea</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Respiratory polygraphy</intervention_name>
    <description>The respiratory polygraphy consisted of continuous polygraphical recordings for a whole night from 22:00 h to 07:00 h with standardised equipment</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary referral hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients after extubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  non-consciousness&#xD;
&#xD;
          -  received continuous positive airway pressure (CPAP)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaeyoung Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 2, 2019</last_update_submitted>
  <last_update_submitted_qc>December 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jaeyoung Cho</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Sleep Apnea</keyword>
  <keyword>Respiratory polygraphy</keyword>
  <keyword>Extubation</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>
  </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/NCT03770715
org study id: 1802051921
nct id: NCT03770715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sleep apnea is common after extubation, approximately 71%, and is independently associated
      with hypertension and metabolic disease contributing to increased morbidity and mortality.
      Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the
      management of more symptomatic patients with obstructive sleep apnea.

      The aim of this study is to evaluate the prevalence of sleep apnea after extubation by
      respiratory polygraphy.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of sleep apnea after exutbation
time frame: during first to second night following extubation
intervention type: Device
intervention name: Respiratory polygraphy
description: The respiratory polygraphy consisted of continuous polygraphical recordings for a whole night from 22:00 h to 07:00 h with standardised equipment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jaeyoung Cho, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jaeyoung Cho
investigator title: Assistant Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes