<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/NCT02211404</url>
  </required_header>
  <id_info>
    <org_study_id>13-00326</org_study_id>
    <nct_id>NCT02211404</nct_id>
  </id_info>
  <brief_title>Children's Sleep in the ICU</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>James Hungerford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <brief_summary>
    <textblock>
      Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide&#xD;
      Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 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>Total Sleep Time</measure>
    <time_frame>24 Hours</time_frame>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Children Admitted to the Intensive Care Unit</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children admitted to the Intensive Care Unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient admitted to the Intensive Care Unit, or soon to be admitted to the ICU&#xD;
&#xD;
          -  Age from 0 days to 17 years 364 days at the time of enrollment&#xD;
&#xD;
          -  Any patient with anticipated ICU stay of at least overnight with a minimum of 12 hours&#xD;
             duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient with Admitted with Traumatic Brain Injury, Admitted with an Active Seizure&#xD;
             Disorder, Severe Developmental Delay that might impair normal sleep architecture,&#xD;
             Known abnormal EEG, any patient actively receiving Mechanical Ventilation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>October 19, 2016</last_update_submitted>
  <last_update_submitted_qc>October 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>James Hungerford</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT02211404
org study id: 13-00326
nct id: NCT02211404
lead sponsor: 
Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide
      Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit
observational model: Cohort
time perspective: Prospective
measure: Total Sleep Time
time frame: 24 Hours
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: James Hungerford
investigator title: Principal Investigator