Observational Study Using the CoVa Monitoring System 3

Completed

• Conditions: Healthy
• Interventions: Device: Cova Monitoring System 3

• Registration Number: NCT03884582
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Status Verified: 2019-04
• Study Start: 2019-04-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HealthyVolunteers	Cova Monitoring System 3	-

Primary Outcome Measures

Name	Time	Method
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues	2 Weeks	Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.

Secondary Outcome Measures

Name	Time	Method
Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.	2 Weeks	Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor while the subject is moving in the bed.

Trial Locations

Locations (1)

toSense,Inc.; 🇺🇸 San Diego, California, United States