PneumoniaSMARTCOUGH-C-2NCT03392363
Diagnosing Respiratory Disease in Children Using Cough Sounds 2
An observational study of Pneumonia and Bronchiolitis, run by ResApp Health Limited at 3 sites in United States.
Trial summary
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection… Read more about this study
- Who is it for?
- Ages 29 days to 12 years
- Conditions the study is for
- Pneumonia, Bronchiolitis, Asthma Exacerbation
- What is being tested?
- Recordings of Infants and Children's Cough Sounds
- Type of treatment
- Medical device
- How many people
- 1,470 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jan 2018to 19 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with signs or symptoms of respiratory disease presenting to participating Emergency Departments, Urgent Care Clinics, Outpatient Clinics or an Inpatient Ward within 24 hours of admission.
Who may be able to join
- Infant or child aged greater than 29 days up to and including their 12th birthday (infant and children pediatric subgroups as defined in Guidance for Industry and Food and Drug Administration Staff: Premarket Assessment of Pediatric Medical Devices dated March 24, 2014)
- Presenting to the study site (an outpatient facility, an urgent care center, an Emergency Department, or inpatient ward within 24 hours of admission) with current signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, nasal congestion/rhinorrhea, abnormal lung sounds on exam or cyanosis/hypoxemia.
- Onset of symptoms within past 14 days
- Outpatient or inpatient within 24 hours of admission
- Coughing spontaneously or able to cough voluntarily
Who cannot join
- 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, CPAP, or BiPAP)) or high flow nasal cannula
- History of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)
- Any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month
- Too medically unstable to participate in study per treating clinician
- Subject previously enrolled in SMARTCOUGH-C-2 study
- Tracheostomy present or tube placed
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic Children's
Cleveland, Ohio, 44195
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).
- Conditions
- Pneumonia, Bronchiolitis, Asthma Exacerbation, Croup, Reactive Airway Disease, Upper Respiratory Disease
- Being tested
- Recordings of Infants and Children's Cough Sounds
- Medical subject headings
- Pneumonia, Bronchiolitis, Croup, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recordings of Infants and Children's Cough SoundsDevice
Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of pneumonia
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with (1) World Health Organization (WHO) Primary Endpoint Pneumonia (PEP) plus clinical pneumonia, (2) WHO PEP or Other Infiltrate plus clinical pneumonia, (3) Clinical pneumonia alone
Measured: 6 months
Diagnosis of other childhood respiratory diseases
Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract disease (i.e. respiratory condition occurring below the level of the larynx), viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease, and croup.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start5 Jan 2018
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResApp Health Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, The Cleveland Clinic, Baylor College of Medicine, Baim Institute for Clinical Research
- Responsible party
- Sponsor
- Investigators
- Peter P Moschovis, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392363
- Sponsor's protocol ID
- 17001
- Acronym
- SMARTCOUGH-C-2
- Status last verified
- Nov 2018
- First submitted
- 29 Dec 2017
- Last updated
- 8 Nov 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2
- ClinicalTrials.gov ID
- NCT03392363
- Acronym / sponsor ID
- SMARTCOUGH-C-2 / 17001
- Conditions
- Pneumonia, Bronchiolitis, Asthma Exacerbation, Croup, Reactive Airway Disease, Upper Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,470 participants (actual)
- Lead sponsor
- ResApp Health LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, The Cleveland Clinic, Baylor College of Medicine, Baim Institute for Clinical Research
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 29 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with signs or symptoms of respiratory disease presenting to participating Emergency Departments, Urgent Care Clinics, Outpatient Clinics or an Inpatient Ward within 24 hours of admission.
Key inclusion criteria (5 listed)
- Infant or child aged greater than 29 days up to and including their 12th birthday (infant and children pediatric subgroups as defined in Guidance for Industry and Food and Drug Administration Staff: Premarket Assessment of Pediatric Medical Devices dated March 24, 2014)
- Presenting to the study site (an outpatient facility, an urgent care center, an Emergency Department, or inpatient ward within 24 hours of admission) with current signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, nasal congestion/rhinorrhea, abnormal lung sounds on exam or cyanosis/hypoxemia.
- Onset of symptoms within past 14 days
- Outpatient or inpatient within 24 hours of admission
- Coughing spontaneously or able to cough voluntarily
Key exclusion criteria (8 listed)
- 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, CPAP, or BiPAP)) or high flow nasal cannula
- History of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)
- Any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recordings of Infants and Children's Cough SoundsSmartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease. | Device | – |
Primary outcome
Diagnosis of pneumonia
Time frame: 6 months
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with (1) World Health Organization (WHO) Primary Endpoint Pneumonia (PEP) plus clinical pneumonia, (2) WHO PEP or Other Infiltrate plus clinical pneumonia, (3) Clinical pneumonia alone
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 disease (i.e. respiratory condition occurring below the level of the larynx), viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease, and croup.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter P Moschovis, MD, MPH principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Bronchiolitis, run by ResApp Health Limited at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of pneumonia (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.