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| Name | Class |
|---|---|
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
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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:
Participants will use the device under controlled conditions and have the following parameters measured before and after standing up:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | ISO-101 Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Magnitude and duration of treatment effect on blood pressure | From date of enrollment until end of study completion (24 hours) |
| Cardiovascular variablity | Changes in peripheral vascular resistance (dyn*s*m2/cm5) and sympathetic nervous system activity (heart rate variability) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neil Fawkes, MBChB DPM FFPM | Contact | +44 (0) 2830 835 500 | neil@isotechltd.co.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust | Recruiting | Newcastle upon Tyne | United Kingdom |
Protocol, ICF will be made avalible as supplementary material along with a manscript once the study and data analysis has been completed.
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| From date of enrollment until end of study completion (24 hours) |
| Erganomics | Number of participants able to effectively use the device | From date of enrollment until end of study completion (24 hours) |
| 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) |
| Investigator feedback | Global impression score | From date of enrollment until end of study completion (24 hours) |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |