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Observational Study Using the CoVa Monitoring System 3

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03884582
Enrollment
14
Registered
2019-03-21
Start date
2019-04-01
Completion date
2019-05-01
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

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.

Interventions

DEVICECova Monitoring System 3

Healthy Volunteers

Sponsors

Baxter Healthcare Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues2 WeeksSubjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.

Secondary

MeasureTime frameDescription
Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.2 WeeksSubjects 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026