Clinical Validation of Omron WheezeScan

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

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Bronchiolitis; Bronchitis

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Naoto Ohgami; Phone Number: +81-75-925-2304; Email: naoto.ogami@omron.com
• Study Contact Backup: Name: Katie May; Email: katie.may@omron.com

Study Locations

• United States
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Completed
      • Tekton Research
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Brenda Louise Giles, MD
    • Joliet, Illinois, United States, 60435
      • Completed
      • PMG Research of DuPage
  • New York
    • New York, New York, United States, 11042
      • Recruiting
      • Long Island Jewish Medical Center
      • Contact: Maria Santiago, MD
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Completed
      • PMG Research of Raleigh
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • PMG Research of Winston-Salem
      • Contact: William Stewart, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Children's Hospital Medical Center
      • Contact: Rachelle Ramsey, MD
      • Contact: Sophie Kollin
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Completed
      • PMG Research of Charleston
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Completed
      • Meridian Clinical Research, LLC
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Completed
      • Pmg Research of Bristol
    • Jefferson City, Tennessee, United States, 37760
      • Completed
      • PMG Research of Knoxville
  • Texas
    • Beaumont, Texas, United States, 77706
      • Recruiting
      • Tekton Research
      • Contact: Robert Bell, MD
    • San Antonio, Texas, United States, 78240
      • Completed
      • Tekton Research
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • Tekton Research
      • Contact: Kenneth Etokhana, MD
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin
      • Contact: Manish N Shah, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Novemver 1, 2019 ~ November 30, 2021

Collaborators and Investigators

• Sponsor: Omron Healthcare Co., Ltd.
• Collaborators: University of Chicago; University of Wisconsin, Madison; Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ANTICIPATED): November 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (ACTUAL): October 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: wheeze; rhonchus
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis; Bronchitis
• Other Study ID Numbers: HDV-CDD-190046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No