Clinical Trial: Diagnosing Respiratory Disease in Children Using Cough Sounds

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

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.

Detailed Summary:
Sponsor: ResApp Health Limited

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: 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, upper respiratory tract infection and/or croup, as compared with a clinical diagnosis.


Information By: ResApp Health Limited

Dates:
Date Received: November 22, 2016
Date Started: December 2016
Date Completion: June 2017
Last Updated: April 13, 2017
Last Verified: April 2017