A Single-center, Randomized Controlled Pilot Trial to Evaluate Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The number of hypotension symptom events
研究概览
简要总结
This clinical trial is an exploratory study aimed at assessing the efficacy and safety of a digital therapeutic for managing symptoms of hypotension, with the goal of providing evidence for the design of future confirmatory clinical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant and Sub-investigator
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 and older with symptoms suspected to be related to dizziness due to hypotension within the past year.
- •Individuals who are able to walk and can participate in the study using a smartphone, or for whom cooperation from a guardian is available.
排除标准
- •Individuals diagnosed with causes of dizziness other than hypotension, such as benign paroxysmal positional vertigo or stroke, within the past year.
- •Severe anemia (history of Hb < 8.0 g/dL within the last 3 months).
- •Individuals unable to use a smartphone (Android phone) or smartwatch.
- •Individuals with a life expectancy of less than 1 year due to diseases such as malignant tumors.
- •Individuals diagnosed with severe heart valve disease or severe heart failure with LVEF < 35% (based on the most recent examination).
- •Recent rapid and unintended weight loss (5% or more, or 5 kg or more, within the last 6 months).
研究组 & 干预措施
Early intervention group (EIG)
the trial group that begins treatment in the 3-week of the total 15-week study period
干预措施: digital therapeutics (Device)
Late intervention group (LIG)
the comparator group that begins treament in the 9-week of the total 15-week study period
干预措施: digital therapeutics (Device)
结局指标
主要结局
The number of hypotension symptom events
时间窗: within the first 6weeks after intervention
The effectiveness of symptom improvement for hypotension was evaluated in the trial and control groups based on the frequency of hypotension symptoms over a 6-week period.
次要结局
- Number of symptoms related to hypotension(over 15weeks)
- Number of falling accident(over 15weeks)
- Details for disease diagnosis and concomitant medications(over 15weeks)
- The frequency of use of digital therapeutics(at 15weeks)