OBPM_FORESEE2024: Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk in a Multi-ethnic European Population: an Observational Cohorts' Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aktiia SA
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors
研究概览
简要总结
Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.
详细描述
ARM 1:
N1~ 3'300 subjects.
Research participants are Aktiia G1 users with Android operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with Android operating system. ARM 1 research participants are asked to:
- For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project,
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment.
- Additionally, once the Aktiia One App is released and for the next 10 years:
- Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.
ARM 2:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects aged 21 to 85 years old
- •Subjects living in Switzerland, Germany or in the UK
- •Subjects that are:
- •Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users owning a smartphone with iOS or Android operating system (ARM 3)
- •Subjects agreeing to follow the study procedures.
排除标准
- •Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting tachycardia (heart rate at rest > 120bpm) and atrial fibrillation;
- •Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula;
- •Subjects suffering from polyneuropathy;
- •on pregnant women;
- •Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements)
- •Subjects with amputated index fingers (for camera measurements) or amputated upper limb;
- •Subjects below 21 years old and above 85 years old.
结局指标
主要结局
Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors
时间窗: 10 years
Strength and direction of the correlation coefficient between continuous blood pressure readings and various survey-derived factors such as sociodemographic variables, lifestyle habits, and health metrics.
次要结局
- Global scale projections of the benefit of the early awareness of hypertension with the spot-check Aktiia G2C device at the fingertip(10 years)