Clinical Validation of Omron WheezeScan

Omron Healthcare

Status: Unknown

Conditions: Bronchiolitis; Asthma in Children; Bronchitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04144699

HDV-CDD-190046

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 3 months to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible.

1. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis?
2. Is the subject between the ages of 3 months to 8 years old?
3. 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.

1. Does the subject have skin rashes or wounds on the chest?

2. Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin?

3. Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)?

4. Does the subject have an allergy to disinfecting alcohol?

5. Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis?

6. Does the subject have a heavy runny nose?

7. Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection?

8. Is the subject having difficulty breathing or having severe symptoms?

9. 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).

Trial design

240 participants in 8 patient groups

Wheezing 3~11months

Description:

Patient has wheezing, age 3 to 11 months

Wheezing 12~23months

Description:

Patient has wheezing, age 12 to 23 months

Wheezing 24~35months

Description:

Patient has wheezing, age 24 to 35 months

Wheezing 36~107months

Description:

Patient has wheezing, age 36 to 107 months

No wheezing 3~11months

Description:

Patient do not have wheezing, age 3 to 11 months

No wheezing 12~23months

Description:

Patient do not have wheezing, age 12 to 23 months

No wheezing 24~35months

Description:

Patient do not have wheezing, age 24 to 35 months

No wheezing 36~107months

Description:

Patient do not have wheezing, age 36 to 107 months