Orthostatic Hypotension
Conditions
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.
Interventions
DEVICEISO-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
Sponsors
Newcastle-upon-Tyne Hospitals NHS Trust
Isotech Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Erganomics | From date of enrollment until end of study completion (24 hours) | Number of participants able to effectively use the device |
| Blood pressure | From date of enrollment until end of study completion (24 hours) | Magnitude and duration of treatment effect on blood pressure |
| Investigator feedback | From date of enrollment until end of study completion (24 hours) | Global impression score |
| 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 |
| 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) |
Countries
United Kingdom
Contacts
Primary ContactNeil Fawkes, MBChB DPM FFPM
Outcome results
None listed