ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00901433
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : June 24, 2009
Sponsor:
Information provided by:
KarmelSonix Ltd.

May 11, 2009
May 13, 2009
June 24, 2009
January 2009
April 2009   (Final data collection date for primary outcome measure)
Safety will be evaluated by success rate of task performance. [ Time Frame: At the end of the study meeting ]
Same as current
Complete list of historical versions of study NCT00901433 on ClinicalTrials.gov Archive Site
  • Number of questions addressed to the investigator required by the participant in order to complete tasks. [ Time Frame: during the study ]
  • 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. ]
Same as current
Not Provided
Not Provided
 
Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Asthma
Device: Personal WheezoMeter
pulmonary sounds analyzer
A
Usability study of the Personal Wheezometer
Intervention: Device: Personal WheezoMeter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
April 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00901433
KSI-PW-US-01
No
Not Provided
Not Provided
Dr. Hanna Levy - Director of clinical studies, KarmelSonix Ltd
KarmelSonix Ltd.
Not Provided
Study Director: Hanna Levy, Dr. KarmelSonix Ltd.
KarmelSonix Ltd.
May 2009