Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- 24-hour M2VS system multimodal vital sign monitoring
- Questionnaire regarding the usability and wearability
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Basel, Switzerland
Lead sponsor
evismo AG
Collaborator
Bern University of Applied Sciences
Collaborator
Source ClinicalTrials.gov