A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.
NCT ID: NCT06039410
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-12-15
2024-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
ISO-101 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Isotech Ltd
INDUSTRY
Responsible Party
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Locations
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Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ISO0001
Identifier Type: -
Identifier Source: org_study_id
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