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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jens Eckstein, Prof. Dr.
- 전화번호: +41 613287689
- 이메일: jens.eckstein@usb.ch
연구 장소
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, 스위스, 4031
- University Hospital Basel
-
연락하다:
- Prof. Dr. med. Jens Eckstein, PhD
- 전화번호: 0041-61-3287689
- 이메일: jens.eckstein@usb.ch
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Strong signal-to-noise ratio
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Similarity of ECG signal compared to Standard of Care
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Jens Eckstein, Prof. Dr., University Hospital, Basel, Switzerland
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-01087; am25eckstein2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .