Orthostatic HypotensionNCT06039410
A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.
A study testing ISO-101 in people with Orthostatic Hypotension, run by Isotech Ltd at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- ISO-101
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Dr Frith, MBChB FRCP PhD, james.frith@newcastle.ac.uk
About this study
Official title: ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study
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
Read the 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.
- Conditions
- Orthostatic Hypotension
- Being tested
- ISO-101
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISO-101Device
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | ISO-101 Device Receives: Device: ISO-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (mmHg)
The change in resting BP, standing BP and postural BP drop during and immediately after using the device.
Measured: From date of enrollment until end of study completion (24 hours)
Adverse Events
Adverse events
Measured: From date of enrollment until end of study completion (24 hours)
Secondary outcomes (5)
Blood pressure
Magnitude and duration of treatment effect on blood pressure
Measured: 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)
Measured: From date of enrollment until end of study completion (24 hours)
Erganomics
Number of participants able to effectively use the device
Measured: 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
Measured: From date of enrollment until end of study completion (24 hours)
Investigator feedback
Global impression score
Measured: From date of enrollment until end of study completion (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start15 Dec 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039410
- Sponsor's protocol ID
- ISO0001
- Status last verified
- Feb 2024
- First submitted
- 1 Sep 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol, ICF will be made avalible as supplementary material along with a manscript once the study and data analysis has been completed.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study
- ClinicalTrials.gov ID
- NCT06039410
- Acronym / sponsor ID
- ISO0001
- Conditions
- Orthostatic Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Isotech LtdIndustry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: ISO-101ISO-101 Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISO-101ISO-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 | Device | Treatment |
Primary outcome
Blood pressure (mmHg)
Time frame: 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
Time frame: From date of enrollment until end of study completion (24 hours)
Adverse events
5 secondary outcomes
Blood pressure
Time frame: From date of enrollment until end of study completion (24 hours)
Cardiovascular variablity
Time frame: From date of enrollment until end of study completion (24 hours)
Erganomics
Time frame: From date of enrollment until end of study completion (24 hours)
Post study participant questionaire
Time frame: From date of enrollment until end of study completion (24 hours)
Investigator feedback
Time frame: From date of enrollment until end of study completion (24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISO-101 in people with Orthostatic Hypotension, run by Isotech Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil Fawkes, MBChB DPM FFPM (+44 (0) 2830 835 500, neil@isotechltd.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (mmHg) (time frame: From date of enrollment until end of study completion (24 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.