Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00901433

Enrollment

Registered

2009-05-13

Start date

2009-01-31

Completion date

2009-04-30

Last updated

2009-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Wheeze Rate, Respiratory Function Tests

Brief summary

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.

Interventions

DEVICEPersonal WheezoMeter

pulmonary sounds analyzer

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety will be evaluated by success rate of task performance.	At the end of the study meeting

Secondary

Measure	Time frame
Number of questions addressed to the investigator required by the participant in order to complete tasks.	during the study
User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems.	At the end of the study meeting.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026