Healthy Clinical Trial
Official title:
Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3
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 |
Verified date | April 2019 |
Source | toSense, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | toSense,Inc. | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
toSense, Inc. |
United States,
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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