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CompletedNCT02973282SMARTCOUGH-CUpdated Jan 5, 2018

Diagnosing Respiratory Disease in Children Using Cough Sounds

An observational study in Pneumonia, Bronchiolitis and Asthma, sponsored by ResApp Health Limited. Completed at 3 sites in United States. Open to participants aged 29 Days to 12 Years. Per ClinicalTrials.gov, last updated 2018-01-05.

Sponsored by ResApp Health Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,245
Ages
29 Days to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia
  • Bronchiolitis
  • Asthma
  • Croup
  • Upper Respiratory Tract Infection
  • Lower Respiratory Tract Infection
  • Reactive Airway Disease
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,245 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

ResApp Health Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 12 Years
Sexes eligible
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,245 participants (actual)
Patient registry
No

Interventions

  • OtherRecording 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

3 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Cleveland Clinic Children's
    Cleveland, Ohio 44195, United States
  • Texas Children's Hospital
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02973282
Lead sponsor
ResApp Health Limited
Collaborators
Massachusetts General Hospital, The Cleveland Clinic, Baylor College of Medicine
Responsible party
Sponsor
First posted
Nov 25, 2016
Start date
Dec 2016
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Jan 5, 2018

Study contacts

Peter P Moschovis, MD, MPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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