Diagnosing Respiratory Disease in Children Using Cough Sounds

Asthma Clinical Trial

— SMARTCOUGH-C  

Official title:

Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973282
• Other study ID #: 16001
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: January 3, 2018
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: ResApp Health Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1245
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Bronchiolitis
• Communicable Diseases
• Croup
• Infection
• Lower Respiratory Tract Infection
• Pneumonia
• Reactive Airway Disease
• Respiration Disorders
• Respiratory Tract Diseases
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Other:
• Recording of Infants and Children's Cough Sounds
Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Children's	Cleveland	Ohio
United States	Texas Children's Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
ResApp Health Limited	Massachusetts General Hospital, Texas Children's Hospital, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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