Observational Study Using the CoVa Monitoring System 3

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03884582
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Actual Duration (Days): 30
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Cova Monitoring System 3

Study Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	toSense,Inc.	San Diego	California	United States	92121

Sponsors and Collaborators

• Baxter Healthcare Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT03884582
• Other Study ID Numbers: RMD-IRB-0001
• First Posted: Mar 21, 2019
• Last Update Posted: Jan 29, 2020
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Baxter Healthcare Corporation: Healthy volunteers

Study Results

No Results Posted as of Jan 29, 2020