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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901433
• Other study ID #: KSI-PW-US-01
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: June 23, 2009
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: KarmelSonix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Personal WheezoMeter
pulmonary sounds analyzer

Locations

Country	Name	City	State
Israel	RAMBAM Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
KarmelSonix Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be evaluated by success rate of task performance.		At the end of the study meeting	Yes
Secondary	Number of questions addressed to the investigator required by the participant in order to complete tasks.		during the study	No
Secondary	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.	No