A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.: a Prospective Single-center Observational Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The percentage of subjects with undiagnosed hypertension
研究概览
简要总结
To screen for and identify subjects with potential undiagnosed hypertension using an optical blood pressure monitoring device across an active workforce population in the US (Nucor employees).
详细描述
100 voluntary Nucor facility employees with no previous diagnosis of hypertension will be recruited and will receive an optical blood pressure monitoring device (Aktiia G1 Device) that is a miniature bracelet placed in the wrist and measure blood pressure continuously without inflating.
Each participant will wear the device continually during 28 days.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects aged 25 to 70 years old.
- •People who self-report that they do not have a diagnosis of hypertension.
- •People employed as a Nucor team member.
- •People who can read and speak English.
- •People who use either an iOS or Android smart phone.
- •Subjects who agree to follow study procedures.
- •Subjects who have signed the informed consent form.
排除标准
- •Subjects with a known diagnosis of i. atrial fibrillation ii. congestive heart failure iii. heart valve disease iv. pheochromocytoma v. Raynaud's disease vi. arm lymphedema.
- •Subjects who take insulin.
- •Subjects who are on hemodialysis.
- •Women who are known to be pregnant.
- •Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
- •Subjects who do not have two arms.
- •Subjects with upper arm circumference < 22cm or > 42cm.
- •Subjects with wrist circumference > 23cm.
结局指标
主要结局
The percentage of subjects with undiagnosed hypertension
时间窗: Each participant will wear the device continuously for 28 days.
Analysis of the percentage of subjects with undiagnosed hypertension defined as an average daytime SBP\>130 or DBP\>80 mmHg over the initial 7 days of the Aktiia 24/7 device use.
次要结局
未报告次要终点