Diagnosing Respiratory Disease in Children Using Cough Sounds

Status:	Completed
Conditions:	Asthma, Asthma, Bronchitis, Pneumonia, Infectious Disease, Pulmonary, Pulmonary
Therapuetic Areas:	Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any - 12
Updated:	1/7/2018
Start Date:	December 2016
End Date:	December 2017

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.

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

We found this trial at

sites

Cleveland Clinic Children's

Cleveland, Ohio

Principal Investigator: John C Carl, MD

Phone: 216-444-3916

from

Cleveland, OH