<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/NCT02973282</url>
  </required_header>
  <id_info>
    <org_study_id>16001</org_study_id>
    <nct_id>NCT02973282</nct_id>
  </id_info>
  <brief_title>Diagnosing Respiratory Disease in Children Using Cough Sounds</brief_title>
  <acronym>SMARTCOUGH-C</acronym>
  <official_title>Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResApp Health Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ResApp Health Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software&#xD;
      application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis,&#xD;
      asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in&#xD;
      infants and children. Patient's cough sounds will be recorded using a smartphone and analysed&#xD;
      using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis&#xD;
      and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or&#xD;
      patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Diagnosis of pneumonia</measure>
    <time_frame>6 months</time_frame>
    <description>Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a radiologic diagnosis.&#xD;
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a clinical diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of other childhood respiratory diseases</measure>
    <time_frame>6 months</time_frame>
    <description>Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract involvement, bronchiolitis, asthma/reactive airway disease, upper respiratory tract infection and/or croup, as compared with a clinical diagnosis.</description>
  </secondary_outcome>
  <enrollment type="Actual">1245</enrollment>
  <condition>Pneumonia</condition>
  <condition>Bronchiolitis</condition>
  <condition>Asthma</condition>
  <condition>Croup</condition>
  <condition>Upper Respiratory Tract Infection</condition>
  <condition>Lower Respiratory Tract Infection</condition>
  <condition>Reactive Airway Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Recording of Infants and Children's Cough Sounds</intervention_name>
    <description>Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with signs or symptoms of respiratory disease presenting to participating&#xD;
        Emergency Departments, Urgent Care Clinics, Primary Care Clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant or child aged 29 days - 12 years&#xD;
&#xD;
          -  Presenting to the study site with signs or symptoms of respiratory disease including&#xD;
             cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast&#xD;
             breathing, abnormal lung sounds on exam, cyanosis/hypoxemia.&#xD;
&#xD;
          -  Coughing spontaneously or able to cough voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of a signed consent form from parent or legal guardian&#xD;
&#xD;
          -  Lack of signed assent form for children aged 7 years or older who, in the opinion of&#xD;
             the investigator, is able to provide assent based on their age, maturity or&#xD;
             psychological state.&#xD;
&#xD;
          -  Need for mechanical ventilatory support (including invasive, continuous positive&#xD;
             airway pressure, or bilevel positive airway pressure) or high flow nasal cannula&#xD;
&#xD;
          -  Any medical contraindication to voluntary cough, including (only enrolled if coughing&#xD;
             spontaneously): severe respiratory distress, history of pneumothorax,&#xD;
             eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month, or too&#xD;
             medically unstable to participate in study per treating clinician.&#xD;
&#xD;
          -  Subject previously enrolled&#xD;
&#xD;
          -  Tracheostomy present or tube placed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Days</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter P Moschovis, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Children's</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>January 3, 2018</last_update_submitted>
  <last_update_submitted_qc>January 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2018</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</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/NCT02973282
org study id: 16001
nct id: NCT02973282
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software
      application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis,
      asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in
      infants and children. Patient's cough sounds will be recorded using a smartphone and analysed
      using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis
      and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or
      patient.
observational model: Cohort
time perspective: Prospective
measure: Diagnosis of pneumonia
time frame: 6 months
description: Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a radiologic diagnosis.
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a clinical diagnosis.
measure: Diagnosis of other childhood respiratory diseases
time frame: 6 months
description: Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract involvement, bronchiolitis, asthma/reactive airway disease, upper respiratory tract infection and/or croup, as compared with a clinical diagnosis.
intervention type: Other
intervention name: Recording of Infants and Children's Cough Sounds
description: Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 29 Days
maximum age: 12 Years
healthy volunteers: No
last name: Peter P Moschovis, MD, MPH
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bronchiolitis
mesh term: Respiratory Tract Infections
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: No