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

Sponsor

Isotech Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039410

Collaborator

Newcastle-upon-Tyne Hospitals NHS Trust (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension	Device: ISO-101	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
Adverse Events [From date of enrollment until end of study completion (24 hours)]
Adverse events

Secondary Outcome Measures

Blood pressure [From date of enrollment until end of study completion (24 hours)]
Magnitude and duration of treatment effect on blood pressure
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)
Erganomics [From date of enrollment until end of study completion (24 hours)]
Number of participants able to effectively use the device
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne		United Kingdom

Sponsors and Collaborators

Isotech Ltd
Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Isotech Ltd

ClinicalTrials.gov Identifier:

NCT06039410

Other Study ID Numbers:

ISO0001

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension, Orthostatic

Hypotension

Study Results

No Results Posted as of Sep 15, 2023