<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/NCT03823326</url>
  </required_header>
  <id_info>
    <org_study_id>SCH-2155</org_study_id>
    <nct_id>NCT03823326</nct_id>
  </id_info>
  <brief_title>Paediatric Oximetry Algorithms - Normative Data Collection</brief_title>
  <official_title>Paediatric Oximetry Algorithms - Normative Data Collection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Children's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Children's NHS Foundation Trust</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>
      To undertake normative data collection of existing clinical algorithms using existing&#xD;
      oximetry technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached&#xD;
      to also wear an additional oximeter at the same time so that comparisons between two&#xD;
      oximeters and their clinical algorithms can be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</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>Oximetry Raw data</measure>
    <time_frame>Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.</time_frame>
    <description>2 second data dumps of SpO2 signals from an overnight trace</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate Raw data</measure>
    <time_frame>Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection</time_frame>
    <description>2 second data dumps of SpO2 signals from an overnight trace</description>
  </primary_outcome>
  <other_outcome>
    <measure>Age</measure>
    <time_frame>Taken at time of consent</time_frame>
    <description>Age of child at time of oximetry</description>
  </other_outcome>
  <other_outcome>
    <measure>Gender</measure>
    <time_frame>Taken at time of consent</time_frame>
    <description>Gender of child</description>
  </other_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Sleep Apnea Syndromes in Children</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All children aged 1 month - 16 years who are undergoing an overnight pulse oximetry&#xD;
        investigation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children who have been referred for a clinical overnight pulse oximetry test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families who do not understand written English if an interpreter is not present for&#xD;
             clinical reasons&#xD;
&#xD;
          -  Times when the kit is already being used for another recruit&#xD;
&#xD;
          -  If children do not attend with the legal guardian and so informed consent cannot be&#xD;
             signed&#xD;
&#xD;
          -  Patient is deemed too unwell by clinical team to be approached about the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Heather E Elphick, MbChBMDMRCPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Facility</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</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/NCT03823326
org study id: SCH-2155
nct id: NCT03823326
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To undertake normative data collection of existing clinical algorithms using existing
      oximetry technology.
Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached
      to also wear an additional oximeter at the same time so that comparisons between two
      oximeters and their clinical algorithms can be compared.
observational model: Cohort
time perspective: Prospective
measure: Oximetry Raw data
time frame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.
description: 2 second data dumps of SpO2 signals from an overnight trace
measure: Pulse Rate Raw data
time frame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection
description: 2 second data dumps of SpO2 signals from an overnight trace
measure: Age
time frame: Taken at time of consent
description: Age of child at time of oximetry
measure: Gender
time frame: Taken at time of consent
description: Gender of child
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 16 Years
last name: Heather E Elphick, MbChBMDMRCPH
role: Principal Investigator
affiliation: Sheffield Children's Hospital
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
sharing ipd: No