Observational Study Using the CoVa Monitoring System 3

NCT ID: NCT03884582

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-05-01

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HealthyVolunteers

Cova Monitoring System 3

Intervention Type DEVICE

Healthy Volunteers

Interventions

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Cova Monitoring System 3

Healthy Volunteers

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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toSense,Inc.

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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RMD-IRB-0001

Identifier Type: -

Identifier Source: org_study_id

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