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

This study has been completed.
Sponsor:
Information provided by:
KarmelSonix Ltd.
ClinicalTrials.gov Identifier:
NCT00901433
First received: May 11, 2009
Last updated: June 23, 2009
Last verified: May 2009
  Purpose

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 Intervention
Asthma
Device: Personal WheezoMeter

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study

Resource links provided by NLM:


Further study details as provided by KarmelSonix Ltd.:

Primary Outcome Measures:
  • Safety will be evaluated by success rate of task performance. [ Time Frame: At the end of the study meeting ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of questions addressed to the investigator required by the participant in order to complete tasks. [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Usability study of the Personal Wheezometer
Device: Personal WheezoMeter
pulmonary sounds analyzer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901433

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

No publications provided

Responsible Party: Dr. Hanna Levy - Director of clinical studies, KarmelSonix Ltd
ClinicalTrials.gov Identifier: NCT00901433     History of Changes
Other Study ID Numbers: KSI-PW-US-01
Study First Received: May 11, 2009
Last Updated: June 23, 2009
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014