Recruiting

WheezeScan

Sponsor:

Omron Healthcare Co., Ltd.

Code:

NCT04144699

Conditions

Asthma in Children

Bronchitis

Bronchiolitis

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Asthma in Children

Bronchitis

Bronchiolitis

Study ID

NCT04144699

Start date

Nov 1, 2019

Status verified date

Sep, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Nov 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

Wheezing 3~11months

Patient has wheezing, age 3 to 11 months

Wheezing 12~23months

Patient has wheezing, age 12 to 23 months

Wheezing 24~35months

Patient has wheezing, age 24 to 35 months

Wheezing 36~107months

Patient has wheezing, age 36 to 107 months

No wheezing 3~11months

Patient do not have wheezing, age 3 to 11 months

No wheezing 12~23months

Patient do not have wheezing, age 12 to 23 months

No wheezing 24~35months

Patient do not have wheezing, age 24 to 35 months

No wheezing 36~107months

Patient do not have wheezing, age 36 to 107 months

Primary outcome measure

  • Evaluate the sensitivity and specificity of the Omron WheezeScan device [ Time Frame: Novemver 1, 2019 ~ November 30, 2021 ]

Central Contacts and Locations

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Long Island Jewish Medical Center

Recruiting

New York, New York, United States, 11042

PMG Research of Winston-Salem

Recruiting

Winston-Salem, North Carolina, United States, 27103

Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Tekton Research

Recruiting

Beaumont, Texas, United States, 77706

Tekton Research

Recruiting

San Antonio, Texas, United States, 78258

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Omron Healthcare Co., Ltd.

Last update posted

Sep 17, 2021

Last verified

Sep, 2021

Keywords

  • wheeze
  • rhonchus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Omron Healthcare Co., Ltd. on 2021-09-17.