<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/NCT02205346</url>
  </required_header>
  <id_info>
    <org_study_id>October 2013</org_study_id>
    <nct_id>NCT02205346</nct_id>
  </id_info>
  <brief_title>Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea</brief_title>
  <official_title>Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Virginia Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medarva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Virginia Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigate urinary leukotriene E4 levels and determine if there is a correlation with&#xD;
      severity of obstructive sleep apnea. The investigators then would like to determine a&#xD;
      threshold level which could then be used for confirmation of diagnosis of obstructive sleep&#xD;
      apnea (OSA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>
  <primary_outcome>
    <measure>urine leukotriene level</measure>
    <time_frame>baseline</time_frame>
    <description>assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>correlation between Urine LTE4 and the apnea hypopnea index (AHI)</measure>
    <time_frame>baseline</time_frame>
    <description>determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>no treatment</arm_group_label>
    <description>no treatment</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      urine sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Otolaryngology practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children 2-16 years of age&#xD;
&#xD;
          -  scheduled for polysomnogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiovascular, neuromuscular, immunologic or craniofacial disorders&#xD;
&#xD;
          -  pharmacologic treatment including corticosteroids and leukotriene receptor antagonists&#xD;
             in the last month&#xD;
&#xD;
          -  subjects who have already received treatment for OSA with an oral appliance,&#xD;
             continuous positive airway pressure (CPAP) device&#xD;
&#xD;
          -  previously undergone tonsillectomy and/or adenoidectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristina Baldassari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>EVMS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of the King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>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>
  <!-- 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/NCT02205346
org study id: October 2013
nct id: NCT02205346
lead sponsor: 
collaborator: 
has dmc: No
Investigate urinary leukotriene E4 levels and determine if there is a correlation with
      severity of obstructive sleep apnea. The investigators then would like to determine a
      threshold level which could then be used for confirmation of diagnosis of obstructive sleep
      apnea (OSA).
observational model: Cohort
time perspective: Prospective
measure: urine leukotriene level
time frame: baseline
description: assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA
measure: correlation between Urine LTE4 and the apnea hypopnea index (AHI)
time frame: baseline
description: determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI
arm group label: no treatment
description: no treatment
urine sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Cristina Baldassari, MD
role: Principal Investigator
affiliation: EVMS
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive