AirSonea Wheeze Detection Study | NCT01927172

Studies
AirSonea Wheeze Detection Study

NCT01927172

Sponsor

iSonea

Status

Unknown status

Last Update Posted

Aug 22, 2013Estimated

Enrollment

85Estimated

Phase

Not Applicable

Conditions

COPD
Asthma

Interventions

AirSonea

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Not provided

First Submitted Date

Aug 2, 2013

First Submission Date that Met QC Criteria

Aug 19, 2013

First Posted Date

Aug 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2013

Last Update Posted Date

Aug 22, 2013Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AirSonea	Other	Use of AirSonea to detect wheeze sounds.	Device: AirSonea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AirSonea	Device		AirSonea	No intervention, AirSonea is an adjuct to physician/clinician auscultation.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001249	Asthma

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided