OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff: a Single-center, Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aktiia SA
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Data set build
研究概览
简要总结
The present study, OBPM_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting ~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2 Bracelet and Aktiia Init I1 oscillometric cuff within a cohort of subjects characterized by a wide variety of phenotypes. The resulting dataset will support research and development activities conducted by AKTIIA SA out of the study context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Subjects aged 21 to 85yo
- •Subjects or witnesses fluent in written and spoken French
- •Subjects agreeing to attend the study visit and follow study procedures
- •Subjects that have signed the informed consent form.
排除标准
- •Amputated index fingers
- •Damaged/injured skin at index fingers
- •Damaged/injured skin at wrists
- •Subjects with tachycardia (heart rate at rest > 120bpm)
- •Subjects with atrial fibrillation
- •Subjects with diabetes
- •Subjects with marked renal dysfunctions (eGFR < 30mL/min/1.73 m2)
- •Subjects with untreated hyper-/hypothyroidism
- •Subjects with pheochromocytoma
- •Subjects with Raynaud's disease
- •Subjects with an arteriovenous fistula
- •Women in known pregnancy
- •History of polyneuropathy
结局指标
主要结局
Data set build
时间窗: Baseline
Number of subjects including three assessments of blood pressure using Aktiia G2C Clinical, alongside three assessments of blood pressure with Aktiia Bracelet G2 and three values of blood pressure generated with the Aktiia Init I1 oscillometric cuff
次要结局
未报告次要终点