NCT01927172
Unknown
N/A
AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- iSonea
- Enrollment
- 85
- Primary Endpoint
- Device Efficacy
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Device Efficacy
Time Frame: 1 day
Device wheeze detection as compared to physician wheeze detection via auscultation.
Secondary Outcomes
- Wheeze Rate break points(Up to 1 week)
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