Observational Study Using the CoVa Monitoring System 3

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Cova Monitoring System 3

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • toSense,Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HealthyVolunteers	Device: Cova Monitoring System 3; Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.	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.	2 Weeks

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: March 17, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: RMD-IRB-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No