ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this clinical trial is to test a novel medical device (ISO-101) in patients diagnosied with orthostatic hypotension. The main question[s] it aims to answer are:
- to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation.
- Assess the safety and performance of the ISO-101 device in patients with orthostatic hypotension.
Participants will use the device under controlled conditions and have the following parameters measured before and after standing up:
- blood pressure
- markers of peripheal vascular resistence
- sympathetic nervous system activity measure before and after standing up
详细描述
This is a proof of principle study aimed at evaluating if there is a signal of efficacy from use of the ISO-101 device in people with orthostatic hypotension. The study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.The primary objective is to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent for participation in the study
- •Adults aged over 18 years with a clinical diagnosis of orthostatic hypotension
- •A drop in systolic BP of ≥20 mmHg (with or without a drop in diastolic BP ≥10 mmHg) within 3 minutes of standing up from a supine position
- •Able to stand up from a supine position (with assistance if required)
排除标准
- •Cognitively unable to follow research procedures
- •Physically unable to use the ISO-101 device (e.g., unilateral arm weakness due to stroke)
- •Acute or reversible cause of OH (e.g., haemorrhage or sepsis)
- •Current pregnancy
- •Participants on insulin (participants will be asked to refrain from breakfast on the morning of their assessment)
- •Resting supine systolic BP ≥180 or diastolic ≥110 mmHg
研究组 & 干预措施
Treatment
ISO-101 Device
干预措施: ISO-101 (Device)
结局指标
主要结局
Adverse Events
时间窗: From date of enrollment until end of study completion (24 hours)
Adverse events
Blood pressure (mmHg)
时间窗: From date of enrollment until end of study completion (24 hours)
The change in resting BP, standing BP and postural BP drop during and immediately after using the device.
次要结局
- Cardiovascular variablity(From date of enrollment until end of study completion (24 hours))
- Post study participant questionaire(From date of enrollment until end of study completion (24 hours))
- Investigator feedback(From date of enrollment until end of study completion (24 hours))
- Blood pressure(From date of enrollment until end of study completion (24 hours))
- Erganomics(From date of enrollment until end of study completion (24 hours))