Cough Count Validation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cough count
研究概览
简要总结
People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.
The assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.
详细描述
Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways . While the cough reflex is essential in protecting the lung from foreign materials and infection, its excessive or chronic presence is both bothersome and might interfere with the quality of life, sleep pattern and exercise tolerance of the patient. Such a symptom may potentially be indicative of an on-going pathological process , .
People with respiratory infection, asthmatic patients and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.
The assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.
The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-80 years.
- •Patients with significant chronic cough.
- •Patients in hemodynamic stability. Patient is not in respiratory distress.
- •Subject or subject's parents/guardians is able to comprehend and give informed consent for participation in the study.
排除标准
- •Contraindication to the use of the PulmoTrack™ or performing ARM (Acoustic Respiratory Monitoring).
- •Hemodynamic instability and/or SOB.
- •Concurrent additional major illness.
- •Concurrent participation in any other study.
- •Physician objection
结局指标
主要结局
Cough count
时间窗: recording lasting up to 24 hours
次要结局
- WheezeRate (the proportion of wheezing in the respiratory cycle) , respiratory rate, Inspiratory/Expiratory ratio, SPO2, symptom score (according to a questioner)(recording lasting up to 24 hours)