Diagnosing Respiratory Disease in Children Using 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.

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Key information

Conditions

Pneumonia Asthma Bronchial Diseases Bronchiolitis Bronchitis Chronic Disease Croup Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Laryngeal Diseases Laryngitis Lower Respiratory Tract Infection Lung Diseases Lung Diseases, Obstructive Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Reactive Airway Disease Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Upper Respiratory Tract Infection

Age range

29 day–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recording of Infants and Children's Cough Sounds

Other

Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

ResApp Health Limited

Industry

Collaborators

Baylor College of Medicine
Massachusetts General Hospital
The Cleveland Clinic

Registry information

Official study title

Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

Acronym: SMARTCOUGH-C

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 25, 2016
Registry last updated: Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed