Diagnosing Respiratory Disease in Children Using Cough Sounds (SMARTCOUGH-C)

• ClinicalTrials.gov Identifier: NCT02973282
• Recruitment Status: Completed
• First Posted: November 25, 2016
• Last Update Posted: January 5, 2018
• Sponsor: ResApp Health Limited
• Collaborators: Massachusetts General Hospital; The Cleveland Clinic; Baylor College of Medicine
• Information provided by (Responsible Party): ResApp Health Limited

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
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: December 2016
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: December 2017

Groups and Cohorts

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with signs or symptoms of respiratory disease presenting to participating Emergency Departments, Urgent Care Clinics, Primary Care Clinics

Criteria

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

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Ohio

Cleveland Clinic Children's

Cleveland, Ohio, United States, 44195

United States, Texas

Texas Children's Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

ResApp Health Limited

Massachusetts General Hospital

The Cleveland Clinic

Baylor College of Medicine

Investigators

• Principal Investigator: Peter P Moschovis, MD, MPH; Massachusetts General Hospital

More Information

• Responsible Party: ResApp Health Limited
• ClinicalTrials.gov Identifier: NCT02973282
• Other Study ID Numbers: 16001
• First Posted: November 25, 2016
• Last Update Posted: January 5, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Infection; Communicable Diseases; Respiratory Tract Infections; Pneumonia; Bronchiolitis; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive