Asthma in ChildrenNCT04144699
Clinical Validation of Omron WheezeScan
An observational study of Asthma in Children and Bronchitis, run by Omron Healthcare Co., Ltd. at 15 sites in United States.
Trial summary
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020. Read more about this study
- Who is it for?
- Ages 3 months to 8 years
- Conditions the study is for
- Asthma in Children, Bronchitis, Bronchiolitis
- How many people
- 240 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Nov 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 8 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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?
Show all 11Show fewer
- 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).
Trial locations and contacts
15 sites in 1 country.
Katie May contact
15 sites in 1 country
United States15 sites, 7 recruiting
- Recruiting
Tekton Research
Beaumont, Texas, 77706
Robert Bell, MD
- Completed
PMG Research of Bristol
Bristol, Tennessee, 37620
- Completed
Tekton Research
Chamblee, Georgia, 30341
- Completed
PMG Research of Charleston
Charleston, South Carolina, 29403
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Brenda Louise Giles, MD
- Recruiting
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rachelle Ramsey, MD
Sophie Kollin
- Completed
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, 57049
- Completed
PMG Research of Knoxville
Jefferson City, Tennessee, 37760
- Completed
PMG Research of DuPage
Joliet, Illinois, 60435
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Manish N Shah, MD, MPH
- Recruiting
Long Island Jewish Medical Center
New York, New York, 11042
Maria Santiago, MD
- Completed
PMG Research of Raleigh
Raleigh, North Carolina, 27609
- Completed
Tekton Research
San Antonio, Texas, 78240
- Recruiting
Tekton Research
San Antonio, Texas, 78258
Kenneth Etokhana, MD
- Recruiting
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
William Stewart, MD
About this study
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
- Keywords
- wheeze, rhonchus
- Medical subject headings
- Bronchitis, Bronchiolitis, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of the Omron WheezeScan device
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.
Measured: Novemver 1, 2019 ~ November 30, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omron Healthcare Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison, Children's Hospital Medical Center, Cincinnati, University of Chicago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144699
- Sponsor's protocol ID
- HDV-CDD-190046
- Status last verified
- Sep 2021
- First submitted
- 28 Oct 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share the data
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Omron WheezeScan
- ClinicalTrials.gov ID
- NCT04144699
- Acronym / sponsor ID
- HDV-CDD-190046
- Conditions
- Asthma in Children, Bronchitis, Bronchiolitis
- Keywords
- wheeze, rhonchus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Omron Healthcare Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison, Children's Hospital Medical Center, Cincinnati, University of Chicago
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the sensitivity and specificity of the Omron WheezeScan device
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: No. No plan to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie May contact
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Bronchitis, run by Omron Healthcare Co., Ltd. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naoto Ohgami (+81-75-925-2304, naoto.ogami@omron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the sensitivity and specificity of the Omron WheezeScan device (time frame: Novemver 1, 2019 ~ November 30, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.