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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Usability study of the Personal Wheezometer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal WheezoMeter | Device | pulmonary sounds analyzer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated by success rate of task performance. | At the end of the study meeting |
| Measure | Description | Time Frame |
|---|---|---|
| Number of questions addressed to the investigator required by the participant in order to complete tasks. | during the study | |
| User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Levy, Dr. | KarmelSonix Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAMBAM Health Care Campus | Haifa | 31096 | Israel |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| At the end of the study meeting. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |