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Clinical Trials/NCT03884582
NCT03884582
Completed
Not Applicable

Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3

Baxter Healthcare Corporation1 site in 1 country14 target enrollmentApril 1, 2019
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Baxter Healthcare Corporation
Enrollment
14
Locations
1
Primary Endpoint
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. These symptoms are particularly prevalent at night-time. Understanding and tracking these symptoms can lead to better management of asthma.

Auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night.

The aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the CoVa patch.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
May 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participant is between the ages of 4 - 17 years old at the time of consent
  • Participant and/or family member/carer willing to give written consent
  • Participant and/or family member/carer who can read and comprehend english

Exclusion Criteria

  • Subject believed to be unsuitable for inclusion by the Principle Investigator
  • Subject is pregnant at time of consent
  • Subject is currently enrolled in another medical study

Outcomes

Primary Outcomes

Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues

Time Frame: 2 Weeks

Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.

Secondary Outcomes

  • Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.(2 Weeks)

Study Sites (1)

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