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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Massachusetts General Hospital

The Cleveland Clinic

Texas Children's Hospital

Information provided by (Responsible Party):

ResApp Health Limited

ClinicalTrials.gov Identifier:

NCT02973282

First received: November 22, 2016

Last updated: July 5, 2017

Last verified: July 2017

History of Changes

Purpose

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.

Condition	Intervention
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
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds

Resource links provided by NLM:

MedlinePlus related topics: Cough

U.S. FDA Resources

Further study details as provided by ResApp Health Limited:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	1245
Study Start Date:	December 2016
Estimated Study Completion Date:	July 2017
Estimated Primary Completion Date:	July 2017 (Final data collection date for primary outcome measure)

Intervention Details:

Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease

Eligibility


Ages Eligible for Study:	up to 12 Years (Child)
Sexes Eligible for Study:	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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02973282

Locations


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

Sponsors and Collaborators

ResApp Health Limited

Massachusetts General Hospital

The Cleveland Clinic

Texas Children's Hospital

Investigators


Principal Investigator:	Peter P Moschovis, MD, MPH	Massachusetts General Hospital

More Information


Responsible Party:	ResApp Health Limited
ClinicalTrials.gov Identifier:	NCT02973282 History of Changes
Other Study ID Numbers:	16001
Study First Received:	November 22, 2016
Last Updated:	July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Infection Communicable Diseases Pneumonia Bronchiolitis Respiratory Tract Infections Respiration Disorders	Respiratory Tract Diseases Bronchial Hyperreactivity Lung Diseases Bronchitis Bronchial Diseases Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on August 18, 2017

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