Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System
Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Jens Eckstein, Prof. Dr.
- Número de telefone: +41 613287689
- E-mail: jens.eckstein@usb.ch
Locais de estudo
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Suíça, 4031
- University Hospital Basel
-
Contato:
- Prof. Dr. med. Jens Eckstein, PhD
- Número de telefone: 0041-61-3287689
- E-mail: jens.eckstein@usb.ch
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Holter cohort
Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period.
|
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.
|
|
ABPM cohort
Participants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Strong signal-to-noise ratio
Prazo: 24 hours
|
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.
|
24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Similarity of ECG signal compared to Standard of Care
Prazo: 24 hours
|
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.
|
24 hours
|
|
Similarity of Systolic Blood Pressure compared to Standard of Care
Prazo: 24 hours
|
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.
|
24 hours
|
|
Similarity of Diastolic Blood Pressure compared to Standard of Care
Prazo: 24 hours
|
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.
|
24 hours
|
|
Reliability compared to Standard of Care
Prazo: 24 hours
|
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.
|
24 hours
|
|
Wearability of M2VS
Prazo: After the 24-hour monitoring period
|
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.
|
After the 24-hour monitoring period
|
|
Localization of Physical Discomfort
Prazo: 24 hours (Upon device removal)
|
Participant-reported areas of discomfort marked on a body map and supplemented by qualitative notes on the corresponding area.
|
24 hours (Upon device removal)
|
|
Acceptance compared to Standard of Care
Prazo: 24 hours (Upon device removal)
|
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.
|
24 hours (Upon device removal)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jens Eckstein, Prof. Dr., University Hospital, Basel, Switzerland
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-01087; am25eckstein2
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .