Self Operating of the Personal WheezoMeter by Intended Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. Furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty.

Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. This usability study was designed to test independent home use and device interface effectiveness of the Personal WheezoMeter in order to validate its safe and effective use by intended users.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Usability study of the Personal Wheezometer

Personal WheezoMeter

Intervention Type DEVICE

pulmonary sounds analyzer

Interventions

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Personal WheezoMeter

pulmonary sounds analyzer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male/female age 18 years and up.
* Subject is diagnosed as an asthmatic, or subject is parent/guardian of an asthmatic child age under 18 years.
* Subject understands the study procedure.
* Subject is able to read the User Manual.
* Signed Informed Consent form
* Compliance with study requirements.

Exclusion Criteria

* Major physical, motor, mental, behavioral, or psychiatric limitations.
* Concurrent additional major illness.
* Subject objects to the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes