AirSonea Wheeze Detection Study

AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01927172

Enrollment

Registered

2013-08-22

Start date

2013-09-30

Completion date

Unknown

Last updated

2013-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD

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.

Interventions

DEVICEAirSonea

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Device Efficacy	1 day	Device wheeze detection as compared to physician wheeze detection via auscultation.

Secondary

Measure	Time frame	Description
Wheeze Rate break points	Up to 1 week	Wheeze Rate break points for the user of rescue inhalers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026