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

KarmelSonix

Status: Completed

Conditions: Asthma

Treatments: Device: Personal WheezoMeter

Study type: Observational

Funder types: Industry

Identifiers

NCT00901433

KSI-PW-US-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

A

Description:

Usability study of the Personal Wheezometer

Treatment:

Device: Personal WheezoMeter