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

NCT00901433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2009-06-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Personal WheezoMeter

pulmonary sounds analyzer

Sponsors & Collaborators

  • KarmelSonix Ltd.

    lead INDUSTRY

Principal Investigators

  • Hanna Levy, Dr. · KarmelSonix Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901433 on ClinicalTrials.gov