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

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.

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.