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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901433
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : June 24, 2009
Information provided by:
KarmelSonix Ltd.

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
Asthma Device: Personal WheezoMeter

Study Type : Observational
Estimated 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 : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Usability study of the Personal Wheezometer
Device: Personal WheezoMeter
pulmonary sounds analyzer

Primary Outcome Measures :
  1. Safety will be evaluated by success rate of task performance. [ Time Frame: 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. [ Time Frame: during the study ]
  2. User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems. [ Time Frame: At the end of the study meeting. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901433

RAMBAM Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
KarmelSonix Ltd.
Study Director: Hanna Levy, Dr. KarmelSonix Ltd.

Responsible Party: Dr. Hanna Levy - Director of clinical studies, KarmelSonix Ltd Identifier: NCT00901433     History of Changes
Other Study ID Numbers: KSI-PW-US-01
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: May 2009

Keywords provided by KarmelSonix Ltd.:
Wheeze Rate
Respiratory Function Tests