MedPath

AirSonea Wheeze Detection Study

Not Applicable
Conditions
COPD
Asthma
Registration Number
NCT01927172
Lead Sponsor
iSonea
Brief Summary

The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
85
Inclusion Criteria
  • Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms

  • Part II: Volunteer participants without asthma

  • Part III: Participants with asthma

  • For all parts of study

    • Age: 18 years or older
    • Participant has signed an Informed Consent after having the Study explained to them.
Exclusion Criteria
  • Any medical finding by the physician that would exclude the patient from participating.
  • < than 18 years of age

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Device Efficacy1 day

Device wheeze detection as compared to physician wheeze detection via auscultation.

Secondary Outcome Measures
NameTimeMethod
Wheeze Rate break pointsUp to 1 week

Wheeze Rate break points for the user of rescue inhalers

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.