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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884582
Other study ID # RMD-IRB-0001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date May 1, 2019

Study information

Verified date April 2019
Source toSense, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers
Gender All
Age group 4 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Cova Monitoring System 3
Healthy Volunteers

Locations

Country Name City State
United States toSense,Inc. San Diego California

Sponsors (1)

Lead Sponsor Collaborator
toSense, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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