Validation of the C-mo System - Cough Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 245
- 试验地点
- 13
- 主要终点
- Cough detection (precision and recall)
研究概览
简要总结
The goal of this clinical study is to validate C-mo System's ability to automatically detect and characterise cough, in patients over 2 years old with cough as a key or refractory symptom.
The main questions it aims to answer are:
- Can C-mo System detect cough events? (automatic cough detection)
- Can C-mo System characterise cough events? (calculation of cough intensity, identification of cough type and presence of wheeze in detected coughs)
Participants will be asked to:
- Wear the C-mo Wearable device for 24 hours (1 day);
- Complete a diary with relevant activities throughout the monitoring period;
- Fill-out questionnaires related to coughing frequency and intensity, usability of the device, and impact of cough on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 2 years or older;
- •Patients with symptoms/complaints of cough;
- •Signed Informed Consent (age ≥ 18 years), signed Informed Consent from the parents/legal representative and the patient (16 and 17 years), or signed Informed Assent and Consent (5 years ≤ age ≤ 15 years).
排除标准
- •Presence of musculoskeletal (e.g., severe scoliosis), neurological (e.g., post stroke), cardiac (e.g., unstable angina), cognitive (e.g., dementia) changes, or other significant conditions that hinder the participants from collaborating in the collection of data.
- •Damaged/weakened skin at the C-mo wearable device's placement area (epigastric region).
- •Absence of Informed Consent and/or Assent, as applicable.
结局指标
主要结局
Cough detection (precision and recall)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically detect cough, using precision and recall (percentage - between 0% and 100%), higher scores mean a better outcome.
Cough detection (F1-score)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically detect cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
Cough characterisation (precision, recall and global accuracy)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough, using precision, recall, and global accuracy (percentage - between 0% and 100%), higher scores mean a better outcome.
Cough characterisation (Cohen's Kappa)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Cough characterisation (F1-score)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
Cough characterisation (Matthews correlation coefficient)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Cough frequency (Matthews correlation coefficient)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Cough type percentage (Matthews correlation coefficient)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Cough type percentage (Cohen's Kappa Index)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Wheezing detection (precision, recall, true negative rate, accuracy, and negative predictive value)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using precision, recall, true negative rate, accuracy, and negative predictive value (percentage - between 0% and 100%), higher scores mean a better outcome.
Wheezing detection (F1-score)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
Cough frequency (Cohen's Kappa Index)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Wheezing detection (Matthews correlation coefficient)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Wheezing detection (Cohen's Kappa Index)
时间窗: 24 hours
Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
次要结局
- Cough intensity(24 hours)
- Usability results(24 hours)
- Cough patterns(24 hours)
- Cough perception vs. C-mo System analysis, in relation to gold standard (expert evaluation)(24 hours)