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

• Sponsor: KarmelSonix Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00901433
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: Personal WheezoMeter

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
A Usability study of the Personal Wheezometer	Device: Personal WheezoMeter; pulmonary sounds analyzer

Outcome Measures

Primary Outcome Measures

1. Safety will be evaluated by success rate of task performance. [At the end of the study meeting]

Secondary Outcome Measures

1. Number of questions addressed to the investigator required by the participant in order to complete tasks. [during the study]

2. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAMBAM Health Care Campus	Haifa		Israel	31096

Sponsors and Collaborators

• KarmelSonix Ltd.

Investigators

• Study Director: Hanna Levy, Dr., KarmelSonix Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00901433
• Other Study ID Numbers: KSI-PW-US-01
• First Posted: May 13, 2009
• Last Update Posted: Jun 24, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: Asthma; Wheeze Rate; Respiratory Function Tests
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Jun 24, 2009