Diagnosing Respiratory Disease in Children Using Cough Sounds (SMARTCOUGH-C)
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ClinicalTrials.gov Identifier: NCT02973282 |
Recruitment Status :
Completed
First Posted : November 25, 2016
Last Update Posted : January 5, 2018
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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 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 |

- 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
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973282
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 |
Principal Investigator: | Peter P Moschovis, MD, MPH | Massachusetts General Hospital |
Responsible Party: | ResApp Health Limited |
ClinicalTrials.gov Identifier: | NCT02973282 |
Other Study ID Numbers: |
16001 |
First Posted: | November 25, 2016 Key Record Dates |
Last Update Posted: | January 5, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Infections Communicable Diseases Bronchiolitis Respiratory Tract Infections Respiration Disorders Respiratory Tract Diseases |
Disease Attributes Pathologic Processes Lung Diseases Bronchitis Bronchial Diseases Lung Diseases, Obstructive |