AirSonea Wheeze Detection Study

Not Applicable

• Conditions: COPD; Asthma
• Interventions: Device: AirSonea

• 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

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-19
• Last Update Submitted: 2013-08-19
• Study First Posted: 2013-08-22
• Last Update Posted: 2013-08-22
• Study Start: 2013-09
• Primary Completion: 2014-08

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

Arm && Interventions

Group	Intervention	Description
AirSonea	AirSonea	Use of AirSonea to detect wheeze sounds.

Primary Outcome Measures

Name	Time	Method
Device Efficacy	1 day	Device wheeze detection as compared to physician wheeze detection via auscultation.

Secondary Outcome Measures

Name	Time	Method
Wheeze Rate break points	Up to 1 week	Wheeze Rate break points for the user of rescue inhalers