NCT01927172

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

August 2, 2013

Last Update Submit

August 19, 2013

Conditions

COPDAsthma

Outcome Measures

Primary Outcomes (1)

  • Device Efficacy

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

    1 day

Secondary Outcomes (1)

  • Wheeze Rate break points

    Up to 1 week

Study Arms (1)

AirSonea

OTHER

Use of AirSonea to detect wheeze sounds.

Device: AirSonea

Interventions

AirSoneaDEVICE
Also known as: No intervention, AirSonea is an adjuct to physician/clinician auscultation.
AirSonea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any medical finding by the physician that would exclude the patient from participating.
  • \< than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 22, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Last Updated

August 22, 2013

Record last verified: 2013-08