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

Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039410
• Other study ID #: ISO0001
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Isotech Ltd
• Contact: Neil Fawkes, MBChB DPM FFPM
• Phone: +44 (0) 2830 835 500
• Email: neil[@]isotechltd.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Isotech Ltd	Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Adverse Events	Adverse events	From date of enrollment until end of study completion (24 hours)
Secondary	Blood pressure	Magnitude and duration of treatment effect on blood pressure	From date of enrollment until end of study completion (24 hours)
Secondary	Cardiovascular variablity	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)
Secondary	Erganomics	Number of participants able to effectively use the device	From date of enrollment until end of study completion (24 hours)
Secondary	Post study participant questionaire	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)
Secondary	Investigator feedback	Global impression score	From date of enrollment until end of study completion (24 hours)