SMARTCOUGH-C: Diagnosing Respiratory Disease in Children Using Cough Sounds

Sponsor

ResApp Health Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT02973282

Collaborator

Massachusetts General Hospital (Other), The Cleveland Clinic (Other), Baylor College of Medicine (Other)

1,245

Enrollment

Locations

Duration (Months)

415

Patients Per Site

34.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Outcome Measures

Primary Outcome Measures

Diagnosis of pneumonia [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 [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

Criteria

Ages Eligible for Study:

29 Days to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Cleveland Clinic Children's	Cleveland	Ohio	United States	44195
3	Texas Children's Hospital	Houston	Texas	United States	77030