Clinical Validation of Omron WheezeScan

• Conditions: Bronchitis; Asthma in Children; Bronchiolitis

• Registration Number: NCT04144699
• Lead Sponsor: Omron Healthcare Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-11-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the sensitivity and specificity of the Omron WheezeScan device	Novemver 1, 2019 ~ November 30, 2021	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.

Trial Locations

Locations (12)

Meridian Clinical Research, LLC; 🇺🇸 Dakota Dunes, South Dakota, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

PMG Research of DuPage; 🇺🇸 Joliet, Illinois, United States

PMG Research of Raleigh; 🇺🇸 Raleigh, North Carolina, United States

PMG Research of Knoxville; 🇺🇸 Jefferson City, Tennessee, United States

Tekton Research; 🇺🇸 San Antonio, Texas, United States

Long Island Jewish Medical Center; 🇺🇸 New York, New York, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

PMG Research of Winston-Salem; 🇺🇸 Winston-Salem, North Carolina, United States

Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

PMG Research of Bristol; 🇺🇸 Bristol, Tennessee, United States

PMG Research of Charleston; 🇺🇸 Charleston, South Carolina, United States