A Single-center, Randomized, Double-blind, Sham-controlled, Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of the Digital Therapeutics (One.Dr) to Improve Blood Pressure Drop When Standing in Patients With Suspected Orthostatic Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 主要终点
- The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period
研究概览
简要总结
Participants who meet the inclusion/exclusion criteria in the Screening visit are randomly assigned 1:1 to the treatment group or the sham control group. The two-week period after Screening is the Run-in period, and the participant performs self-measured blood pressure monitoring, records data using the One.Dr application, and records symptoms and events related to orthostatic hypotension such as dizziness in the application. Only those who have completed the Run-in period will enter the Intervention period (for 6 weeks at 3-8 weeks), and according to each allocation group, non-pharmaceutical treatment education is provided for the treatment group and general health knowledge education is provided for the sham control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 19 years of age suspected of orthostatic hypotension due to symptoms such as dizziness within one year
- •Participants who are able to walk and conduct this clinical trial or cooperate with their care providers
排除标准
- •Participants diagnosed with diseases that cause dizziness other than orthostatic hypotension, such as otolithiasis and stroke, within one year
- •Severe anemia (Hb <8.0 g/dL, based on the latest test results within 12 months)
- •Participants unable to use smartphones (android phones) and/or smart watches
- •Participants with chronic diseases less than one year of life expectancy, such as malignant tumors
- •Participants with severe heart valve disease or severe heart failure (LVEF <35%) who have been hospitalized for acute exacerbation within the last 3 months
- •Participants with recent rapid and unintended weight loss (5% or more than 5 kg within 6 months)
结局指标
主要结局
The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period
时间窗: For 8 weeks after first use of digital therapeutics
Orthostatic BP will be recorded during the Run-in period (2 wks) and the Intervetion period (6 wks). The orthostatic BP drops are expected to decrease in the treatment group than in the sham control group.
次要结局
未报告次要终点