AirSonea Wheeze Detection Study

N/AUnknownNCT01927172

iSonea85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

COPD Asthma

Interventions

AirSoneaDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Time frame: 1 day

Secondary Outcomes

Wheeze Rate break points

Wheeze Rate break points for the user of rescue inhalers

Time frame: Up to 1 week

Data from ClinicalTrials.gov

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