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

Primary Purpose

Orthostatic Hypotension

Status

Not yet recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

ISO-101

About this trial

This is an interventional treatment trial for Orthostatic Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

ISO-101 Device

Outcomes

Primary Outcome Measures

Blood pressure (mmHg)

The change in resting BP, standing BP and postural BP drop during and immediately after using the device.

Adverse Events

Adverse events

Secondary Outcome Measures

Blood pressure

Magnitude and duration of treatment effect on blood pressure

Cardiovascular variablity

Changes in peripheral vascular resistance (dyn*s*m2/cm5) and sympathetic nervous system activity (heart rate variability)

Erganomics

Number of participants able to effectively use the device

Post study participant questionaire

7 point Likert Scale covering the following domains; usefulness, ease of use, ease of learning, satisfaction and intention to use

Investigator feedback

Global impression score

Full Information

NCT ID

NCT06039410

First Posted

September 1, 2023

Last Updated

September 8, 2023

Sponsor

Isotech Ltd

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT06039410

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Isotech Ltd

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthostatic Hypotension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

ISO-101 Device

Intervention Type

Device

Intervention Name(s)

ISO-101

Intervention Description

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

Primary Outcome Measure Information:

Title

Blood pressure (mmHg)

Description

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)

Title

Adverse Events

Description

Adverse events

Time Frame

From date of enrollment until end of study completion (24 hours)

Secondary Outcome Measure Information:

Title

Blood pressure

Description

Magnitude and duration of treatment effect on blood pressure

Time Frame

From date of enrollment until end of study completion (24 hours)

Title

Cardiovascular variablity

Description

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)

Title

Erganomics

Description

Number of participants able to effectively use the device

Time Frame

From date of enrollment until end of study completion (24 hours)

Title

Post study participant questionaire

Description

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)

Title

Investigator feedback

Description

Global impression score

Time Frame

From date of enrollment until end of study completion (24 hours)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Neil Fawkes, MBChB DPM FFPM

Phone

+44 (0) 2830 835 500

neil@isotechltd.co.uk

Facility Information:

Facility Name

Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust

City

Newcastle Upon Tyne

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Frith, MBChB FRCP PhD

james.frith@newcastle.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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