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.
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.
Study Type
OBSERVATIONAL
Enrollment
20
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
Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Strong signal-to-noise ratio
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.
Time frame: 24 hours
Similarity of ECG signal compared to Standard of Care
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.
Time frame: 24 hours
Similarity of Systolic Blood Pressure compared to Standard of Care
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.
Time frame: 24 hours
Similarity of Diastolic Blood Pressure compared to Standard of Care
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.
Time frame: 24 hours
Reliability compared to Standard of Care
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.
Time frame: 24 hours
Wearability of M2VS
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.
Time frame: After the 24-hour monitoring period
Localization of Physical Discomfort
Participant-reported areas of discomfort marked on a body map and supplemented by qualitative notes on the corresponding area.
Time frame: 24 hours (Upon device removal)
Acceptance compared to Standard of Care
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.
Time frame: 24 hours (Upon device removal)
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