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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
ISO-101 is an experimental wearable class 1 medical device which when used is able to raise the blood pressure upon standing via controlled isometric muscular contractions
Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
RECRUITINGBlood pressure (mmHg)
The change in resting BP, standing BP and postural BP drop during and immediately after using the device.
Time frame: From date of enrollment until end of study completion (24 hours)
Adverse Events
Adverse events
Time frame: From date of enrollment until end of study completion (24 hours)
Blood pressure
Magnitude and duration of treatment effect on blood pressure
Time frame: From date of enrollment until end of study completion (24 hours)
Cardiovascular variablity
Changes in peripheral vascular resistance (dyn\*s\*m2/cm5) and sympathetic nervous system activity (heart rate variability)
Time frame: From date of enrollment until end of study completion (24 hours)
Erganomics
Number of participants able to effectively use the device
Time frame: From date of enrollment until end of study completion (24 hours)
Post study participant questionaire
7 point Likert Scale covering the following domains; usefulness, ease of use, ease of learning, satisfaction and intention to use
Time frame: From date of enrollment until end of study completion (24 hours)
Investigator feedback
Global impression score
Time frame: From date of enrollment until end of study completion (24 hours)
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