A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device
研究概览
简要总结
The main purpose of this study in healthy participants is to find out whether the traditional ambulatory blood pressure monitor (ABPM) and newer wearable devices (EmbracePlus smartwatch device, Biobeat chest patch device, and Aktiia wrist device) will accurately pick up changes in blood pressure caused by 2 different medications (propranolol and pseudoephedrine). The study will last about 29 days excluding the screening period of 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females
- •Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
- •Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- •Have given written informed consent approved by Lilly and the ethical review board governing the site
排除标准
- •Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Have history of sensitive skin or chronic skin conditions, like eczema
- •Regular use of known drugs of abuse
- •Are women who are pregnant or lactating
- •Have known allergies to medications used in the study
研究组 & 干预措施
ABPM + Wearable Novel Devices + Propranolol
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with propranolol administered orally for 5 days in one of three study periods.
干预措施: Propranolol (Drug)
ABPM + Wearable Novel Devices + Propranolol
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with propranolol administered orally for 5 days in one of three study periods.
干预措施: ABPM and Wearable Novel Devices (Device)
ABPM + Wearable Novel Devices + Pseudoephedrine
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with pseudoephedrine administered orally for 5 days in one of three study periods.
干预措施: Pseudoephedrine (Drug)
ABPM + Wearable Novel Devices + Pseudoephedrine
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with pseudoephedrine administered orally for 5 days in one of three study periods.
干预措施: ABPM and Wearable Novel Devices (Device)
ABPM + Wearable Novel Devices Only
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.
干预措施: ABPM and Wearable Novel Devices (Device)
ABPM + Wearable Novel Devices Only
Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.
干预措施: No Intervention (Other)
结局指标
主要结局
The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device
时间窗: Baseline through 48 hours
The Mean Change in SBP Using Chest Patch Device
次要结局
- The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device(Baseline through 48 hours)
- The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM)(Baseline through 48 hours)
- The Mean Change in SBP Using Wrist Device(Baseline through 48 hours)
- The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM(Baseline through 48 hours)
- The Mean Change in SBP Using Chest Patch Device and Wrist Device(Baseline through 120 hours)
- The Mean Change in DBP Using Chest Patch Device and Wrist Device(Baseline through 120 hours)