Clinical Validation of Omron WheezeScan

Study Overview
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Brief Summary
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The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.

Official Title
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Clinical Validation of Omron WheezeScan

Conditions
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Asthma in Children, Bronchitis, Bronchiolitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis? Is the subject between the ages of 3 months to 8 years old? Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf. Exclusion Criteria: The subjects will be excluded from the study, if they have any of the following criteria. Does the subject have skin rashes or wounds on the chest? Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin? Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)? Does the subject have an allergy to disinfecting alcohol? Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis? Does the subject have a heavy runny nose? Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection? Is the subject having difficulty breathing or having severe symptoms? Was the subject enrolled more than once for the same resulted breath sounds? Note: The subject maybe enrolled once per arm (once wheezing, once non-wheezing).

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wheezing 3 11months<br>Patient has wheezing, age 3 to 11 months | |
| Wheezing 12 23months<br>Patient has wheezing, age 12 to 23 months | |
| Wheezing 24 35months<br>Patient has wheezing, age 24 to 35 months | |
| Wheezing 36 107months<br>Patient has wheezing, age 36 to 107 months | |
| No wheezing 3 11months<br>Patient do not have wheezing, age 3 to 11 months | |
| No wheezing 12 23months<br>Patient do not have wheezing, age 12 to 23 months | |
| No wheezing 24 35months<br>Patient do not have wheezing, age 24 to 35 months | |
| No wheezing 36 107months<br>Patient do not have wheezing, age 36 to 107 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensitivity and specificity of the Omron WheezeScan device | The WheezeScan device will be compared to the gold standard, auscultation, which will be performed by a physician or a qualified healthcare professional with a minimum of 3 years' experience. All breath sounds will be recorded for comparison in case of discrepancy. | Novemver 1, 2019   November 30, 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheeze, rhonchus