Clinical trial NCT04144699: Clinical Validation of Omron WheezeScan
Official title: Clinical Validation of Omron WheezeScan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma in Children
Bronchitis
Bronchiolitis
Keywords: wheeze
rhonchus
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Wisconsin, Madison
name: Children's Hospital Medical Center, Cincinnati
name: University of Chicago
First posted: 2019-10-30
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wheezing Total : Min.120, Wheezing 3\~11months : Min.19, Wheezing 12\~23months : Min.19, Wheezing 24\~35months : Min.19, Wheezing 36\~107months : Min.38, No wheezing total : Min.120, No wheezing 3\~11months : Min.19, No wheezing 12\~23months : Min.19, No wheezing 24\~35months : Min.19, No wheezing 36\~107months : Min.38

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


Eligibility criteria: 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).

Primary outcomes:
measure: Evaluate the sensitivity and specificity of the Omron WheezeScan device
timeFrame: Novemver 1, 2019 ~ November 30, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Chamblee
country: United States
facility: Tekton Research
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: PMG Research of DuPage
state: Illinois
city: New York
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Charleston
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research, LLC
state: South Dakota
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Jefferson City
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Beaumont
country: United States
facility: Tekton Research
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: