A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.

Study Overview
=================
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 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

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, 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.

Official Title
-----------------
ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study

Conditions
-----------------
Orthostatic Hypotension

Intervention / Treatment
-----------------
* Device: ISO-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Thus, the study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>ISO-101 Device | Device: ISO-101<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (mmHg) | The change in resting BP, standing BP and postural BP drop during and immediately after using the device. | From date of enrollment until end of study completion (24 hours) | 
| Adverse Events | Adverse events | From date of enrollment until end of study completion (24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Magnitude and duration of treatment effect on blood pressure | 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) | From date of enrollment until end of study completion (24 hours) | 
| Erganomics | Number of participants able to effectively use the device | 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 | From date of enrollment until end of study completion (24 hours) | 
| Investigator feedback | Global impression score | From date of enrollment until end of study completion (24 hours) |