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

Not Applicable

Recruiting

• Conditions: Orthostatic Hypotension

• Registration Number: NCT06039410
• Lead Sponsor: Isotech Ltd

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.

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2023-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events	From date of enrollment until end of study completion (24 hours)	Adverse events
Blood pressure (mmHg)	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular variablity	From date of enrollment until end of study completion (24 hours)	Changes in peripheral vascular resistance (dyn\*s\*m2/cm5) and sympathetic nervous system activity (heart rate variability)
Post study participant questionaire	From date of enrollment until end of study completion (24 hours)	7 point Likert Scale covering the following domains; usefulness, ease of use, ease of learning, satisfaction and intention to use
Investigator feedback	From date of enrollment until end of study completion (24 hours)	Global impression score
Blood pressure	From date of enrollment until end of study completion (24 hours)	Magnitude and duration of treatment effect on blood pressure
Erganomics	From date of enrollment until end of study completion (24 hours)	Number of participants able to effectively use the device

Trial Locations

Locations (1)

Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle Upon Tyne, United Kingdom