Monitoring Cough Device - Step 1 and 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Accuracy of Cough Device
研究概览
简要总结
The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.
Cough is an important defense mechanism of the respiratory tract. The presence of chronic cough may indicate the presence of underlying diseases, including reflux. Despite the increased number of patients suffering from cough in the ENT and GI practice, to date, there has been no method/device to objectively assess the frequency of cough episodes in a given patient.
PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an innovative device that is able to record cough episodes and then automatically detect and count them with the help of a specific software program. This study will assess the accuracy of this novel cough monitoring and counting technology and validate potential clinical use in patients with chronic cough.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Arm 1: healthy volunteers:
- •Male and female volunteers 18 years of age and older
- •No history of chronic or acute cough and throat clearing
- •Ability to read a 5th grade script written in English for approximately 20 minutes
- •Arm 2: patients:
- •Male and female volunteers 18 years of age and older
- •Cough as chief complaint
- •Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint
- •pH testing for standard of care purposes
排除标准
- •Subjects who are not able to give informed consent
结局指标
主要结局
Accuracy of Cough Device
时间窗: 24 hours post device placement
The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.
次要结局
未报告次要终点
研究者
Michael Vaezi
Medical Director
Vanderbilt University