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Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System

2026年7月3日 更新者：University Hospital, Basel, Switzerland

Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.

In this study, the investigators want to find out whether a new wearable sensor system, called the M2VS system, can reliably measure heart activity, blood pressure, and other vital signs over 24 hours during normal daily life.

The investigators also want to compare the M2VS system with the standard devices currently used for long-term heart and blood pressure monitoring, such as a Holter ECG and an ambulatory blood pressure monitor (ABPM). This will provide an estimation of the accuracy of the M2VS system's ECG and blood pressure measurements compared to the standard devices.

The aim of the study is to assess how reliable the M2VS system is in terms of data completeness and how comfortable it is to wear compared with the usual monitoring devices.

In the future, the results of this study may help make the monitoring of heart and blood vessel diseases more comfortable and easier for patients.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. Long-term ambulatory monitoring of electrocardiography (ECG) and blood pressure is essential for the detection and management of conditions such as paroxysmal atrial fibrillation and masked hypertension. However, current standard monitoring devices, including Holter ECG monitors and ambulatory blood pressure monitors, may be limited by reduced wearing comfort, skin irritation from adhesive electrodes, motion artefacts, and discontinuous blood pressure measurements.

This feasibility study evaluates a novel wearable sensor system, the M2VS system, designed as a flexible textile-based band integrating dry electrodes and multiple sensors for continuous multimodal vital signs monitoring. The system records ECG, photoplethysmography (PPG), inertial measurement unit (IMU) data, body temperature, bioimpedance, acoustic respiratory signals, and piezo sensor data over a 24-hour period in daily life. In this study, the M2VS system will be used strictly as a non-diagnostic data logger.

This study will provide critical insights into the signal quality and technical reliability of a non-invasive, multi-sensor wearable compared to current standard of care (Holter monitor and ABPM). By evaluating the wearable, the research aims to overcome the comfort and compliance barriers of existing monitoring systems. These findings may represent a significant step toward developing more reliable, continuous diagnostic tools for the long-term management of conditions like atrial fibrillation and hypertension.

研究类型

观察性的

注册 (估计的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 瑞士
    • Canton of Basel-City
      • Basel、Canton of Basel-City、瑞士、4031
        • University Hospital Basel
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The project population consists of adult participants (≥18 years) recruited at the USB who have a clinical indication for either 24-hour Holter monitoring or 24-hour ABPM. A total of N=20 participants will be enrolled, N=10 for the Holter cohort and N=10 for the ABPM cohort.

描述

Inclusion Criteria:

  • Written informed consent obtained prior to any project-specific procedures.
  • Age 18 years or older at the time of enrolment.
  • Ability to provide valid informed consent.
  • Clinical indication for 24-hour Holter monitoring (Holter cohort) or 24-hour ABPM (ABPM cohort).

Exclusion Criteria:

  • Insufficient knowledge of the German language, preventing adequate understanding of the project procedures and informed consent.
  • Enrolment of the project leader, project staff, their family members, employees, or other dependent persons.

Dermatological and Sensor Placement:

  • Pre-existing skin conditions at the application sites (medial upper arm or chest), such as extensive scarring, tattoos, open wounds, active inflammation, or severe oedema that could interfere with sensor coupling or signal quality.
  • Excessive hair at the application site that could interfere with sensor coupling or signal quality.
  • Presence of other concurrent wearable devices at the same anatomical application site that could interfere with the M2VS system.
  • Known allergy to skin-contacting materials utilized in the M2VS system.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Holter cohort
Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period.
设备：24-hour M2VS system multimodal vital sign monitoring
The study features a dual-device monitoring approach integrated into the clinical routine: Participants receiving standard of care will concurrently wear the M2VS system for a 24-hour recording period.The M2VS system is designed for multimodal vital sign monitoring. It comprises a wearable and an associated belt system. The wearable consists of a battery pack and a recorder unit, that are connected via a sliding mechanism
其他：Questionnaire regarding the usability and wearability
Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.
ABPM cohort
Participants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period.
设备：24-hour M2VS system multimodal vital sign monitoring
The study features a dual-device monitoring approach integrated into the clinical routine: Participants receiving standard of care will concurrently wear the M2VS system for a 24-hour recording period.The M2VS system is designed for multimodal vital sign monitoring. It comprises a wearable and an associated belt system. The wearable consists of a battery pack and a recorder unit, that are connected via a sliding mechanism
其他：Questionnaire regarding the usability and wearability
Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Strong signal-to-noise ratio
大体时间：24 hours
A strong signal-to-noise ratio (dB), ensuring signals received lie within a range that is physiologically feasible and are usable for further vital sign analysis, and the percentage of continuous, gap-free recording time.
24 hours

次要结果测量

结果测量
措施说明
大体时间
Similarity of ECG signal compared to Standard of Care
大体时间：24 hours
Agreement of the ECG signal between the investigational M2VS system and the standard of care reference devices. This evaluates the mean heart rate derived from ECG RR-intervals compared to the 24-hour Holter monitor. The overall similarity is quantified using the Intraclass Correlation Coefficient. This is a Unitless index ranging from 0 to 1.
24 hours
Similarity of Systolic Blood Pressure compared to Standard of Care
大体时间：24 hours
Agreement of systolic blood pressure between the investigational M2VS system and the standard of care reference devices. This evaluates the estimated systolic blood pressure derived from Pulse Arrival Time (using synchronous M2VS ECG and PPG signals) compared to the 24-hour Ambulatory Blood Pressure Monitor (ABPM). The overall similarity for these metrics is quantified using the Intraclass Correlation Coefficient. This is a Unitless index ranging from 0 to 1.
24 hours
Similarity of Diastolic Blood Pressure compared to Standard of Care
大体时间：24 hours
Agreement of diastolic blood pressure between the investigational M2VS system and the standard of care reference devices. This evaluates the estimated diastolic blood pressure derived from Pulse Arrival Time (using synchronous M2VS ECG and PPG signals) compared to the 24-hour Ambulatory Blood Pressure Monitor (ABPM). The overall similarity for these metrics is quantified using the Intraclass Correlation Coefficient. This is a Unitless index ranging from 0 to 1.
24 hours
Reliability compared to Standard of Care
大体时间：24 hours
Quantification of the signal reliability and technical performance of the investigational M2VS system compared to the standard of care reference devices. This evaluates the technical data continuity and signal quality, measured as the percentage of the total recording period where the ECG and PPG data packets are continuous, gap-free, and meet acceptable Signal-to-Noise Ratio (SNR) and physiological thresholds to be considered usable.
24 hours
Wearability of M2VS
大体时间：After the 24-hour monitoring period
Participant-reported wearability of the M2VS system compared to standard of care devices, assessed via a structured questionnaire administered upon device removal. Responses are measured on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores from reverse-coded items will be inverted before the mean score is calculated. A higher mean score indicates better usability and wearability.
After the 24-hour monitoring period
Localization of Physical Discomfort
大体时间：24 hours (Upon device removal)
Participant-reported areas of discomfort marked on a body map and supplemented by qualitative notes on the corresponding area.
24 hours (Upon device removal)
Acceptance compared to Standard of Care
大体时间：24 hours (Upon device removal)
Participant acceptance of the M2VS device compared to standard of care devices, assessed via the Net Promoter Score (NPS). The NPS is calculated using a single question ("How likely are you to recommend...?") on a scale from 0 (not at all likely) to 10 (extremely likely). The final NPS ranges from 0 to 10, where a higher score indicates a higher level of participant acceptance.
24 hours (Upon device removal)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Basel, Switzerland

合作者

Bern University of Applied Sciences
evismo AG

调查人员

  • 首席研究员：Jens Eckstein, Prof. Dr.、University Hospital, Basel, Switzerland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年8月31日

研究注册日期

首次提交

2026年6月25日

首先提交符合 QC 标准的

2026年7月3日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月3日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-01087; am25eckstein2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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