An interventional study of ISO-101 in Orthostatic Hypotension, sponsored by Isotech Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Isotech Ltd · Not applicable, Interventional, and Treatment
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.
155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 113 interventional studies indexed under Hypotension, Orthostatic.
Browse Hypotension, Orthostatic studies →This is the only study on the registry with Isotech Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Blood pressure (mmHg)
The change in resting BP, standing BP and postural BP drop during and immediately after using the device.
Time frame: From date of enrollment until end of study completion (24 hours)
Adverse Events
Adverse events
Time frame: From date of enrollment until end of study completion (24 hours)
Blood pressure
Magnitude and duration of treatment effect on blood pressure
Time frame: 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)
Time frame: From date of enrollment until end of study completion (24 hours)
Erganomics
Number of participants able to effectively use the device
Time frame: 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
Time frame: From date of enrollment until end of study completion (24 hours)
Investigator feedback
Global impression score
Time frame: From date of enrollment until end of study completion (24 hours)
Plan to share: Yes — Protocol, ICF will be made avalible as supplementary material along with a manscript once the study and data analysis has been completed.
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
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