NCT06422468招募中不适用
Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study
Qompium NV2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2024年3月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Identification of morphologic characteristics of smartphone generated signals
研究概览
简要总结
The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria applicable for all groups:
- •At least 18 years old
- •Participants must have the ability to understand and provide written informed consent
- •Participants must have the ability to understand Dutch
- •Group specific inclusion criteria:
- •Group 1: Healthy volunteers
- •No cardiac conditions based on medical history.
- •Group 2: Cardiology patients
- •Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF.
- •Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction).
排除标准
- •Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
- •Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
- •Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
- •Persons that have a disability to perform the measurements according to the instructions for use
- •Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm
结局指标
主要结局
Identification of morphologic characteristics of smartphone generated signals
时间窗: 1 day
Detect or identify specific morphologic characteristics (changes or correlations) by the comparison of PPG signals, accelerometer signals, gyroscope signals, sound signals and ECG signals, derived via the smartphone data.
次要结局
- Evaluate the performance of the FibriCheck Algorithm(1 day)
研究者
研究点 (2)
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