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.

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 Overview

• Status: Unknown
• Conditions: Asthma; COPD
• Intervention / Treatment: Device: AirSonea

• Study Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AirSonea; Use of AirSonea to detect wheeze sounds.	Device: AirSonea; Other Names: No intervention, AirSonea is an adjuct to physician/clinician auscultation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: iSonea

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 22, 2013

Study Record Updates

• Last Update Posted (Estimate): August 22, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: iS-2013-Wz