Clinical Validation of Omron WheezeScan

Status unconfirmed

Conditions studied: Asthma in Children, Bronchitis, Bronchiolitis

In brief

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

Key facts

Study ID

NCT04144699

Run by

Omron Healthcare Co., Ltd.

People needed

240

Starts

2019-11-01

Expected to finish

2021-12-31

Last updated by the study team

2021-09-17

Who can join

Age: 0 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States (enrolling)
• Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Tekton Research — Beaumont, Texas, United States (enrolling)
• Long Island Jewish Medical Center — New York, New York, United States (enrolling)
• Tekton Research — San Antonio, Texas, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Tekton Research — San Antonio, Texas, United States
• PMG Research of Charleston — Charleston, South Carolina, United States
• PMG Research of DuPage — Joliet, Illinois, United States
• PMG Research of Raleigh — Raleigh, North Carolina, United States
• Tekton Research — Chamblee, Georgia, United States
• Meridian Clinical Research, LLC — Dakota Dunes, South Dakota, United States
• PMG Research of Bristol — Bristol, Tennessee, United States
• PMG Research of Knoxville — Jefferson City, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.