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

Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Asthma; Bronchiolitis; Lower Respiratory Tract Infection; Croup; Reactive Airway Disease; Upper Respiratory Tract Infection
• Intervention / Treatment: Other: Recording of Infants and Children's Cough Sounds

• Study Type: Observational
• Enrollment (Actual): 1245

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Children's
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of pneumonia	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of other childhood respiratory diseases	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.	6 months

Collaborators and Investigators

• Sponsor: ResApp Health Limited
• Collaborators: Massachusetts General Hospital; Baylor College of Medicine; The Cleveland Clinic
• Investigators: Principal Investigator: Peter P Moschovis, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Infections; Communicable Diseases; Respiratory Tract Infections; Bronchiolitis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 16001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No