Asthma Clinical Trial
— SMARTCOUGH-COfficial title:
Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds
Verified date | January 2018 |
Source | ResApp Health Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
ResApp Health Limited | Massachusetts General Hospital, Texas Children's Hospital, The Cleveland Clinic |
United States,
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 |
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