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

NCT06039410 | Recruiting

• 1 other identifier: ISO0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Orthostatic Hypotension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Blood pressure

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

• Cardiovascular variablity

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

• Erganomics

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

• Post study participant questionaire

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

• Investigator feedback

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

Study Arms (1)

Treatment

EXPERIMENTAL

ISO-101 Device

Device: ISO-101

Interventions

ISO-101 DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Isotech Ltd: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

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

Newcastle upon Tyne, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Neil Fawkes, MBChB DPM FFPM

CONTACT

+44 (0) 2830 835 500; neil@isotechltd.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 15, 2023
• Study Start: December 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

GB (1)