The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
Evaluate the sensitivity and specificity of the Omron WheezeScan device [ Time Frame: Novemver 1, 2019 ~ January 22, 2020 ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
3 Months to 8 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Wheezing 3~11months : 32(min29) Wheezing 12~23months : 32(min29) Wheezing 24~35months : 32(min29) Wheezing 36~107months : 96(min87) No wheezing 3~11months : 32(min29) No wheezing 12~23months : 32(min29) No wheezing 24~35months : 32(min29) No wheezing 36~107months : 96(min91)
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.
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).