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Testing a wearable sensor for 24-hour heart and blood pressure monitoring

Tests a wearable sensor that tracks heart activity and blood pressure over 24 hours.

Key facts

Who runs it
University Hospital, Basel, Switzerland
Where
Basel, SwitzerlandSee the site
Trial code
Registry title
Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System
Status
Not yet recruiting
People taking part
20 people, planned
Started
1 Jul 2026
Planned end
31 Aug 2026
Type of study
Observational, 2 groups
Treatments tested
  • 24-hour M2VS system multimodal vital sign monitoring
  • Questionnaire regarding the usability and wearability
Record updated
10 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have a medical reason for a 24-hour Holter heart monitor or a 24-hour blood pressure monitor. It tests a new wearable sensor.

Age
18 years or older
Sex
All sexes can join

Main reasons for not taking part

  • Not enough German to understand the study and give consent
  • Study leader, study staff, their family members, employees or other dependent persons
  • Skin problems where the sensor goes, such as extensive scarring, tattoos, open wounds, active inflammation or severe swelling
  • Too much hair where the sensor goes
  • Another wearable device on the same body spot, or a known allergy to the sensor's skin-contact materials

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Presence of other concurrent wearable devices at the same anatomical application site that could interfere with the M2VS system
  • 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
  • Known allergy to skin-contacting materials utilized in the M2VS system
  • 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:
  • Excessive hair at the application site that could interfere with sensor coupling or signal quality

Where in Switzerland

  • University Hospital BaselBasel, SwitzerlandContact: Prof. Dr. med. Jens Eckstein, PhDNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Holter cohort

    Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period.

    Treatment: 24-hour M2VS system multimodal vital sign monitoring and Questionnaire regarding the usability and wearability

  • ABPM cohort

    Participants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period.

    Treatment: 24-hour M2VS system multimodal vital sign monitoring and Questionnaire regarding the usability and wearability

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.
Plain-language title
Testing a wearable sensor for 24-hour heart and blood pressure monitoringGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 July 2026