Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Validation of Omron WheezeScan

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.
 
ClinicalTrials.gov Identifier: NCT04144699
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
University of Wisconsin, Madison
Children's Hospital Medical Center, Cincinnati
Le Bonheur Children's Hospital
University of Chicago
Information provided by (Responsible Party):
Omron Healthcare Co., Ltd.

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

Condition or disease
Asthma in Children Bronchitis Bronchiolitis

Layout table for study information
Study Type : Observational
Estimated Enrollment : 384 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Validation of Omron WheezeScan
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144699


Contacts
Layout table for location contacts
Contact: Naoto Ohgami, 37 +81-75-925-2304 naoto.ogami@omron.com
Contact: Tammy Kennedy tammy.kennedy@omron.com

Locations
Layout table for location information
United States, Ohio
Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Rachelle Ramsey         
Contact: Sophie Kollin         
Sponsors and Collaborators
Omron Healthcare Co., Ltd.
University of Wisconsin, Madison
Children's Hospital Medical Center, Cincinnati
Le Bonheur Children's Hospital
University of Chicago

Layout table for additonal information
Responsible Party: Omron Healthcare Co., Ltd.
ClinicalTrials.gov Identifier: NCT04144699    
Other Study ID Numbers: HDV-CDD-190046
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share the data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omron Healthcare Co., Ltd.:
wheeze
rhonchus
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections