Observational Study Using the CoVa Monitoring System 3
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ClinicalTrials.gov Identifier: NCT03884582 |
Recruitment Status :
Completed
First Posted : March 21, 2019
Last Update Posted : January 29, 2020
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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.
Condition or disease | Intervention/treatment |
---|---|
Healthy | Device: Cova Monitoring System 3 |
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 : | April 1, 2019 |
Actual Primary Completion Date : | May 1, 2019 |
Actual Study Completion Date : | May 1, 2019 |
Group/Cohort | Intervention/treatment |
---|---|
HealthyVolunteers |
Device: Cova Monitoring System 3
Healthy Volunteers |
- Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues [ Time Frame: 2 Weeks ]Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.
- Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed. [ Time Frame: 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.

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Ages Eligible for Study: | 4 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884582
United States, California | |
toSense,Inc. | |
San Diego, California, United States, 92121 |
Responsible Party: | toSense, Inc. |
ClinicalTrials.gov Identifier: | NCT03884582 |
Other Study ID Numbers: |
RMD-IRB-0001 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | January 29, 2020 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Healthy volunteers |