ASM in CF:ANNE Sensor Monitoring in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events
研究概览
简要总结
The ANNE sensor is a small, wire free device that is placed on the chest with a removable adhesive patch. It measures things like temperature, heart rate and breathing rate without the need for wires and large machines that are needed currently. The aim is to trial this sensor in a small group of participants to see how well it is tolerated and how well it measures. The aim is to see if the sensor could provide additional information to help the medical team detect when a participant is becoming unwell with less need for the participant to perform repeated tests.
Participants will wear the sensor for 6 weeks continuously (apart from when it is charged for 4-6 hours each day). Participants can perform their usual activities whilst wearing the sensor but should not submerse the sensor in water for long periods of time.
详细描述
Rationale
The aim of this study is to explore the potential use of the ANNE Chest Sensor to assist or improve the detection of health conditions in people with CF. The emphasis is on identifying onset and progression of pulmonary exacerbations.
The ANNE Chest Sensor is now being applied to help people with respiratory and other conditions. Through advanced analytics and signal processing, the device includes an accelerometer, temperature sensor and electrocardiogram, from which vital signs such as respiratory rate, skin and body temperature, ECG, heart rate, step count, fall count and body position can be measured.
Royal Papworth Hospital has demonstrated that daily recordings of a range of physiological parameters (e.g., spirometry, pulse oximetry, activity, heart rate, etc.) in combination with self-reported survey responses (e.g., general wellness, cough, sleep quality) in people with CF holds promise to more accurately track fluctuations in health condition(s), in particular the start of pulmonary exacerbations (PE). This data is collected remotely at the study participant's home using remote/virtual online tools, as part of a larger effort to take a more virtual approach to clinics. Passive and continuous collection of a patient's data for early detection is a natural extension of this approach.
Study Design
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Cystic Fibrosis based on genetic testing and /or sweat chloride levels.
- •At least >/= 18 years of age at time of consent
- •Able to provide written informed consent
- •Patients who are currently undertaking home monitoring / virtual clinics as part of Project Breathe
排除标准
- •Patients unable to provide written informed consent
- •Patients who are currently not undertaking home monitoring / virtual clinics as part of Project Breathe
- •Lung transplant recipients.
- •Severe skin conditions e.g. psoriasis, severe eczema
- •Patients with a pacemaker
结局指标
主要结局
Number of Participants With ANNE Sensor Related Adverse Skin Sensitivity Events
时间窗: 6 weeks
Number of ANNE sensor related Adverse Events reported during the study
次要结局
- Difference in Heart Rate (bpm) Measured by The ANNE Chest Sensor vs Current Heart Rate Home Monitoring(6 weeks)
- Difference in Oxygen Levels (%) Measured by The Anne Chest Sensor vs Current Oxygen Levels Home Measurements(6 weeks)
- Difference in Activity (kcal) Measured by The ANNE Chest Sensor vs Current Home Activity Monitoring(6 weeks)