Piloting the Clinical Value of Wearable Cardiorespiratory Monitoring for People With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Byteflies
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Sensor Dot usability
研究概览
简要总结
Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for long-term monitoring of disease progression and early signs of PEx to intervene as early as possible, thereby improving long-term outcomes.
This in-hospital feasibility study will assess the ability of Byteflies Sensor Dots to collect relevant cardiorespiratory data in people with CF and its compatibility with clinical workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from patients and healthcare providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Confirmed CF diagnosis as determined by a sweat chloride ≥ 60 mmol/L or the presence of two known disease-causing mutations
排除标准
- •Inability to provide written informed consent
- •A known allergy to any of the used medical adhesives
- •Presence of any type of electronic implanted medical device
结局指标
主要结局
Sensor Dot usability
时间窗: Up to 24 hours
Assessed via user (healthcare professional and patient) surveys.
Sensor Dot data quality
时间窗: Up to 24 hours
Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data.
次要结局
- Screen for candidate digital biomarkers in CF(Up to 24 hours)
- Quality of calculated vital signs: heart rate(Up to 24 hours)
- Quality of calculated vital signs: respiratory rate(Up to 24 hours)
- Cough detection(Up to 24 hours)