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Diagnosing Respiratory Disease in Children Using Cough Sounds (SMARTCOUGH-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973282
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
The Cleveland Clinic
Texas Children's Hospital
Information provided by (Responsible Party):
ResApp Health Limited

Tracking Information
First Submitted Date November 22, 2016
First Posted Date November 25, 2016
Last Update Posted Date January 5, 2018
Study Start Date December 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02973282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 13, 2017)
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.
Original Secondary Outcome Measures
 (submitted: November 22, 2016)
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, upper respiratory tract infection and/or croup, as compared with a clinical diagnosis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosing Respiratory Disease in Children Using Cough Sounds
Official Title Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Pneumonia
  • Bronchiolitis
  • Asthma
  • Croup
  • Upper Respiratory Tract Infection
  • Lower Respiratory Tract Infection
  • Reactive Airway Disease
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2017)
1245
Original Estimated Enrollment
 (submitted: November 22, 2016)
1111
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02973282
Other Study ID Numbers 16001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ResApp Health Limited
Study Sponsor ResApp Health Limited
Collaborators
  • Massachusetts General Hospital
  • The Cleveland Clinic
  • Texas Children's Hospital
Investigators
Principal Investigator: Peter P Moschovis, MD, MPH Massachusetts General Hospital
PRS Account ResApp Health Limited
Verification Date January 2018