NCT06356077已完成不适用
SHINE Study: Blood Pressure Evolution and User Satisfaction in a Hypertensive Population Using the Aktiia 24/7 Optical Blood Pressure Monitoring (OBPM) Device: a Prospective Observational Cohort Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aktiia SA
- 入组人数
- 1,729
- 试验地点
- 1
- 主要终点
- Blood Pressure evolution over 12 weeks
研究概览
简要总结
The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).
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
- 否
入选标准
- •Adult participants aged 22 to 85 years old
- •A participant whose last blood pressure reading was within the last 12 months and was either:
- •People who use either an iOS or Android smartphone
- •People who have 2 arms
- •Able and willing to provide informed consent and to adhere to study procedures.
排除标准
- •Participants whose BP data submitted is >180 mm Hg systolic OR >120 mm Hg diastolic .
- •Participants with a self-reported known diagnosis of
- •atrial fibrillation
- •congestive heart failure
- •heart valve disease
- •pheochromocytoma
- •Raynaud's disease
- •arm lymphedema
- •Participants who take insulin
- •Participants who are on hemodialysis
- •Women who are self-reported to be pregnant
- •Participants whose arms shake uncontrollably or are paralyzed (cannot move)
- •Participants with upper arm circumference <22 cm or >42 cm
- •Participants with wrist circumference >23cm
- •Participation in another interventional clinical study or use of investigational drugs in the last 30 days.
结局指标
主要结局
Blood Pressure evolution over 12 weeks
时间窗: 3 months
Means, medians, standard deviations, and ranges for Blood Pressure readings and changes in Blood Pressure readings within the study population between week 1 to week 12.
次要结局
- Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor(3 months)
- Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.(3 months)
研究者
研究点 (1)
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