Status:
RECRUITING
A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.
Lead Sponsor:
Isotech Ltd
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Orthostatic Hypotension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06039410
Start Date
December 15 2023
End Date
March 1 2024
Last Update
February 22 2024
Active Locations (1)
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1
Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom