Evaluation of an Innovative Smart T-shirt Capable to Monitor ECG Signal and Related Parameters Through the Comparison With a Holter ECG and a Smartwatch
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
- Electrocardiogram (ECG): RR interval (seconds)
研究概览
简要总结
Evaluation of an innovative smart t-shirt capable to monitor ECG signal and related parameters through the comparison with a Holter ECG and a smartwatch
详细描述
The primary purpose of this study is to evaluate the biosignal (ECG) acquisition features of the smart t-shirt, developed by University of Bologna in collaboration with AccYouRate S.p.A., comparing it with a standard Holter ECG. Secondly, the study wants to compare the parameters related to ECG signal calculated by the smart t-shirt with those calculated by commercial smartwatches.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects agree to participate in the study and having dated and signed the informed consent form,
- •Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements,
- •Male or female aged ≥ 18 years and ≤ 90 years old,
- •Subjects with Cardiac electrophysiological (heart rhythm) pathologies or under screening for the assessment of possible cardiac electrophysiological pathologies.
排除标准
- •Subjects that for different reasons have difficulties to wear the sensorized t-shirt or the alternative sensorized chest band: Movement's impairments; Dermatological reaction to t-shirt fabric or materials,
- •Any medical or surgical condition that would limit the patient adhesion to the study protocol,
- •Severe obesity and sever underweight,
- •Subject that are not able to understand the scope of the study.
结局指标
主要结局
Electrocardiogram (ECG): RR interval (seconds)
时间窗: 24 hours
Smart t-shirt and ECG Holter comparison
Electrocardiogram (ECG): Qualitative distinction of P-waves, QRS-complexes, T-waves, and noise levels
时间窗: 24 hours
Smart t-shirt and ECG Holter comparison
Electrocardiogram (ECG): Heart rate (beats per minute)
时间窗: 24 hours
Smart t-shirt and ECG Holter comparison
次要结局
- Electrocardiogram (ECG): Heart rate (beats per minute)(24 hours)
研究者
Claudio Borghi
Professor/Dean
University of Bologna