A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age >21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >21 years.
- •Physician-diagnosed COPD at least 6 months prior to screening visit.
- •Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.
- •Free of exacerbation for 1 month before enrollment.
排除标准
- •Unable or willing to sign an informed consent.
- •Unable to complete the 6-minute walk test due to physical or mental health conditions.
- •Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.
- •Pregnancy
- •Study clinician determines that the patient is unable or unwilling to comply with all study procedures.
研究组 & 干预措施
High risk COPD patients
Adults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months.
干预措施: RespirAI (Device)
结局指标
主要结局
Sensitivity
时间窗: 6 months
Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
False alam rate
时间窗: 6 months
The rate of false alarms produced by the device.
次要结局
未报告次要终点