Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety will be evaluated by success rate of task performance.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Major physical, motor, mental, behavioral, or psychiatric limitations.
- •Concurrent additional major illness.
- •Subject objects to the study protocol.
结局指标
主要结局
Safety will be evaluated by success rate of task performance.
时间窗: At the end of the study meeting
次要结局
- 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.(At the end of the study meeting.)