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Diagnosing Respiratory Disease in Children Using Cough Sounds (SMARTCOUGH-C)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by ResApp Health Limited
Sponsor:
Collaborators:
Massachusetts General Hospital
The Cleveland Clinic
Texas Children's Hospital
Information provided by (Responsible Party):
ResApp Health Limited
ClinicalTrials.gov Identifier:
NCT02973282
First received: November 22, 2016
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Pneumonia Bronchiolitis Asthma Croup Upper Respiratory Tract Infection Lower Respiratory Tract Infection Reactive Airway Disease Other: Recording of Infants and Children's Cough Sounds

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

Resource links provided by NLM:


Further study details as provided by ResApp Health Limited:

Primary Outcome Measures:
  • Diagnosis of pneumonia [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures:
  • Diagnosis of other childhood respiratory diseases [ Time Frame: 6 months ]
    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.


Estimated Enrollment: 1111
Study Start Date: December 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Recording of Infants and Children's Cough Sounds
    Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease
  Eligibility

Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with signs or symptoms of respiratory disease presenting to participating Emergency Departments, Urgent Care Clinics, Primary Care Clinics
Criteria

Inclusion Criteria:

  • Infant or child aged 29 days - 12 years
  • Presenting to the study site with signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, abnormal lung sounds on exam, cyanosis/hypoxemia.
  • Coughing spontaneously or able to cough voluntarily

Exclusion Criteria:

  • Lack of a signed consent form from parent or legal guardian
  • Lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state.
  • Need for mechanical ventilatory support (including invasive, continuous positive airway pressure, or bilevel positive airway pressure) or high flow nasal cannula
  • Any medical contraindication to voluntary cough, including (only enrolled if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month, or too medically unstable to participate in study per treating clinician.
  • Subject previously enrolled
  • Tracheostomy present or tube placed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02973282

Contacts
Contact: Kay Taylor, PhD +617 3724 0035 kay@resapphealth.com.au

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Peter P Moschovis, MD MPH    617-643-9687    pmoschovis@mgh.harvard.edu   
Principal Investigator: Peter P Moschovis, MD MPH         
United States, Ohio
Cleveland Clinic Children's Recruiting
Cleveland, Ohio, United States, 44195
Contact: John C Carl, MD    216-444-3916    CARLJ@ccf.org   
Principal Investigator: John C Carl, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Esther M Sampayo, MD MPH    832-824-6512    sampayo@bcm.edu   
Principal Investigator: Esther M Sampayo, MD MPH         
Sponsors and Collaborators
ResApp Health Limited
Massachusetts General Hospital
The Cleveland Clinic
Texas Children's Hospital
Investigators
Principal Investigator: Peter P Moschovis, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: ResApp Health Limited
ClinicalTrials.gov Identifier: NCT02973282     History of Changes
Other Study ID Numbers: 16001
Study First Received: November 22, 2016
Last Updated: April 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Bronchiolitis
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Bronchial Hyperreactivity
Lung Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on June 23, 2017