Clinical trial NCT02973282: Diagnosing Respiratory Disease in Children Using Cough Sounds
Official title: Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Bronchiolitis
Asthma
Croup
Upper Respiratory Tract Infection
Lower Respiratory Tract Infection
Reactive Airway Disease
Lead sponsor: ResApp Health Limited
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: The Cleveland Clinic
name: Baylor College of Medicine
First posted: 2016-11-25
Enrollment: 1245
Sex: ALL
Minimum age (years): 29
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Diagnosis of pneumonia
timeFrame: 6 months
Secondary outcomes:
measure: Diagnosis of other childhood respiratory diseases
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic Children's
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Peter P Moschovis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: