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

February 20, 2024 updated by: Isotech Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom
        • Recruiting
        • Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
ISO-101 Device
Device: ISO-101
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure (mmHg)
Time Frame: 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.
From date of enrollment until end of study completion (24 hours)
Adverse Events
Time Frame: From date of enrollment until end of study completion (24 hours)
Adverse events
From date of enrollment until end of study completion (24 hours)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isotech Ltd

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol, ICF will be made avalible as supplementary material along with a manscript once the study and data analysis has been completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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