Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Difference in Usable ECG
研究概览
简要总结
The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions:
- Can the textile sensors provide continuous monitoring and detect arrhythmias?
- Do patients prefer to wear textile sensors instead of the Holter?
Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.
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
- •Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or suspected cardiovascular disease.
- •Age above 18
- •Understand and speak English enough to consent and answer the study questionnaire.
- •A medical need for Holter monitoring, and having a personal smartphone (iOS or Android), compatible with the Skiin app (application used to monitor the patient using the wearable device)
排除标准
- •Pregnancy
- •Implanted defibrillator or pacemaker
- •Absence of garment fitting the participant's body
- •Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
- •Severe frailty such that donning or doffing the garment may cause a danger of fall.
- •Sensitive skin
结局指标
主要结局
Difference in Usable ECG
时间窗: Throughout the entire data collection period, that is between 1 and 14 days
The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear
Difference in Heart Rate
时间窗: Throughout the entire data collection period, that is between 1 and 14 days
The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear
Difference in RR intervals
时间窗: Throughout the entire data collection period, that is between 1 and 14 days
The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear
Arrhythmic events
时间窗: Throughout the entire data collection period, that is between 1 and 14 days
The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear
次要结局
- Patient's perception(At the end of the study, 1 to 14 days after initiation.)