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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973282
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
The Cleveland Clinic
Baylor College of Medicine
Information provided by (Responsible Party):
ResApp Health Limited

Study Description
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Brief Summary:
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 or disease Intervention/treatment
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 Design
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Study Type : Observational
Actual Enrollment : 1245 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds
Study Start Date : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Pneumonia

Groups and Cohorts
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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

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973282


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
ResApp Health Limited
Massachusetts General Hospital
The Cleveland Clinic
Baylor College of Medicine
Investigators
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Principal Investigator: Peter P Moschovis, MD, MPH Massachusetts General Hospital
More Information
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Responsible Party: ResApp Health Limited
ClinicalTrials.gov Identifier: NCT02973282    
Other Study ID Numbers: 16001
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Pneumonia
Bronchiolitis
Respiration Disorders
 Respiratory Tract Diseases
Lung Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive