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

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT07694570
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 24-hour M2VS system multimodal vital sign monitoring — DEVICE
    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 — OTHER
    Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Holter cohort
    Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period.
  • Arm: ABPM cohort
    Participants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period.

Primary Outcome Measure

Strong signal-to-noise ratio [ Time Frame: 24 hours ]

Central Contacts

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