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Completed

NCT Number: NCT00901433

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RAMBAM Health Care Campus

Haifa, 31096, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personal WheezoMeter

Device

pulmonary sounds analyzer

Primary outcomes

  1. Safety will be evaluated by success rate of task performance.

    Time frame: At the end of the study meeting

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

KarmelSonix Ltd.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 13, 2009
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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