Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedJune 24, 2009
May 1, 2009
3 months
May 11, 2009
June 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety will be evaluated by success rate of task performance.
At the end of the study meeting
Secondary Outcomes (2)
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.
Study Arms (1)
A
Usability study of the Personal Wheezometer
Interventions
Eligibility Criteria
Male/Female participants ages 18 and up that were either diagnosed as an asthmatic or are parent/guardian of an asthmatic child age under 18 years.
You may qualify if:
- 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.
You may not qualify if:
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KarmelSonix Ltd.lead
Study Sites (1)
RAMBAM Health Care Campus
Haifa, 31096, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hanna Levy, Dr.
KarmelSonix Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 13, 2009
Study Start
January 1, 2009
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
June 24, 2009
Record last verified: 2009-05