Clinical trial NCT06039410: A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.
Official title: ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthostatic Hypotension
Lead sponsor: Isotech Ltd
Sponsor class: INDUSTRY
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
First posted: 2023-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure (mmHg)
timeFrame: From date of enrollment until end of study completion (24 hours)
measure: Adverse Events
timeFrame: From date of enrollment until end of study completion (24 hours)
Secondary outcomes:
measure: Blood pressure
timeFrame: From date of enrollment until end of study completion (24 hours)
measure: Cardiovascular variablity
timeFrame: From date of enrollment until end of study completion (24 hours)
measure: Erganomics
timeFrame: From date of enrollment until end of study completion (24 hours)
measure: Post study participant questionaire
timeFrame: From date of enrollment until end of study completion (24 hours)
measure: Investigator feedback
timeFrame: From date of enrollment until end of study completion (24 hours)
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
References: