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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Другое Questionnaire regarding the usability and wearability
  Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.

Первичные конечные точки

• Strong signal-to-noise ratio [Срок оценки: 24 hours]

Вторичные конечные точки (7)

• Similarity of ECG signal compared to Standard of Care [Срок оценки: 24 hours]
• Similarity of Systolic Blood Pressure compared to Standard of Care [Срок оценки: 24 hours]
• Similarity of Diastolic Blood Pressure compared to Standard of Care [Срок оценки: 24 hours]
• Reliability compared to Standard of Care [Срок оценки: 24 hours]
• Wearability of M2VS [Срок оценки: After the 24-hour monitoring period]
• Localization of Physical Discomfort [Срок оценки: 24 hours (Upon device removal)]
• Acceptance compared to Standard of Care [Срок оценки: 24 hours (Upon device removal)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT07694570 · 2026-01087; am25eckstein2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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