HypertensionVISION-RWENCT06325384
Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
A study testing Lifelight and Blood Pressure Cuff in people with Hypertension, run by Xim Limited at 1 site in United Kingdom.
Trial summary
A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lifelight and Blood Pressure Cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Established diagnosis of hypertension
- Uncontrolled hypertension defined as office blood pressure ≥140/90mmHg.
- Patients who are pharmacologically treated for their hypertension should have been on stable medication for at least 4 weeks.
- Ability to read, write and understand English to complete the study.
- Capacity to give free, valid informed consent.
- A compatible device that supports Lifelight®, as per xim Ltd.'s constantly updating list of compatible devices. If this is not possible, xim Ltd, might provide a similar device for the purpose of the study.
Who cannot join
- Patients with stage III hypertension with office blood pressure ≥180/120mmHg or it is unsafe to keep them in the study, in the opinion of the investigators.
- Individuals with diagnosed atrial fibrillation.
- Patients with significant arrhythmias such as SVT (Supraventricular tachycardia) or any rhythm that has significant impact on their BP, poor perfusion, pregnancy, pre-eclampsia, deformities or abnormalities which may prevent proper application of a BP cuff, or skin disorders (anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria)
- Participants who are unwilling to undertake self-monitoring or lacking capacity.
- Partners or spouses of individuals already randomised in the trial
- Patients on dialysis or known ESRD (End-stage kidney disease)
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- Patients on active cancer treatment
- Terminally ill patients
- Patients who cannot tolerate sitting for up to one hour.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square,
London, EC1M 6BQ
Manish Saxena, MBBS, 020 7882 3856, m.saxena@qmul.ac.uk
Armida Balawon, RN, 020 7882 5660, a.balawon@qmul.ac.uk
About this study
Official title: VISION-Real World Evaluation
A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics
Read the detailed description
Suitable patients from the BHT hypertension clinic patient database will be invited to take part in the study, resulting in the recruitment of 500 people aged 18 years or over who have a clinical diagnosis of hypertension that is treated (including via lifestyle interventions) but not controlled (≥140/90mmHg in-clinic measurement of BP). Study nurses at BHT will facilitate this recruitment and randomise participants to either Lifelight® or BP cuff arm using a secure web-based system in 1:1 ratio, minimised on baseline BP, gender, and BP target (standard hypertension, older hypertension and diabetes). They will also collect all baseline study data, including baseline BP measurements.
The HBPM schedule that all participants will be asked to follow for the full 6-month study duration is HBPM using BP cuff or Lifelight® (depending on into which arm of the study they have been randomised) twice in a sitting for two sittings a day for one week every month. All participants will be asked to record their adherence to HBPM in the provided diary (recording the number of repeat measurements made on each day that those measurements are made and notes about any measurement failures). They will also be requested to record in their diary information about their healthcare resource use (GP appointments, outpatients' appointments, hospitalisations, medication and dose changes, medication adherence) and feedback about their HBPM method every month. All participants will also be asked to complete a set of tailored and validated questionnaires in the provided questionnaire booklet: quality of life.
The diaries and questionnaire booklets include instructions to assist with their accurate completion by participants. Participants will be issued with two diaries during their study participation: one at the baseline visit and one at the 3-month visit. They should complete the diary every day that they are doing HBPM. Participants will be issued with 3 questionnaire booklets during their study participation: two at the baseline visit and one at the 3-month visit. They should complete one questionnaire booklet within one week of their baseline visit, the second booklet within one week of their 3-month visit, and the third booklet within one week of their 6-month visit. Participants will be requested to bring back the diary and questionnaire booklet(s) at their subsequent study visit at BHT. Participants randomised to the Lifelight® arm will be prompted via the app to monitor their BP during the relevant weeks.
People eligible to take part in this study will be adults (18+ years old) with treated but uncontrolled hypertension. People with uncontrolled hypertension have the highest risk of CVD events and therefore the value of HBPM could be greatest for these people. The TASMIN and HOME BP studies focussed on this sub-population of patients with hypertension too, suggesting that future guidelines may continue to provide no recommendation of frequent HBPM for people with controlled hypertension, but a change to the guidelines for people with uncontrolled hypertension.
- Conditions
- Hypertension
- Being tested
- Lifelight, Blood Pressure Cuff
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifelightDevice
Contactless Vital Signs Measurement via RPPG
Blood Pressure CuffDevice
Standard Blood Pressure Cuff Digital
| Study group | Role | What they receive |
|---|---|---|
| Cuff Arm | Active comparator | Blood Pressure Cuff Receives: Device: Blood Pressure Cuff |
| LifeLight Arm | Experimental | Contactless Vital Signs Monitor using RPPG Receives: Device: Lifelight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Measurement Non Inferiority
Demonstrate non-inferiority of Lifelight® HBPM compared to cuff-based HBPM for achieving blood pressure control. (5 mmHg non-inferiority margin)
Measured: 3 Months
Secondary outcomes (1)
Adherance to Blood Pressure Measurement
Determine acceptability and adherence of Lifelight® for HBPM in comparison to cuff-based HBPM methods.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start10 Feb 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xim Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust, Mind Over Matter Medtech Ltd, Health Innovation Wessex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325384
- Sponsor's protocol ID
- IRAS ID:321955
- Acronym
- VISION-RWE
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISION-Real World Evaluation
- ClinicalTrials.gov ID
- NCT06325384
- Acronym / sponsor ID
- VISION-RWE / IRAS ID:321955
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xim LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust, Mind Over Matter Medtech Ltd, Health Innovation Wessex
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics
Detailed description
Suitable patients from the BHT hypertension clinic patient database will be invited to take part in the study, resulting in the recruitment of 500 people aged 18 years or over who have a clinical diagnosis of hypertension that is treated (including via lifestyle interventions) but not controlled (≥140/90mmHg in-clinic measurement of BP). Study nurses at BHT will facilitate this recruitment and randomise participants to either Lifelight® or BP cuff arm using a secure web-based system in 1:1 ratio, minimised on baseline BP, gender, and BP target (standard hypertension, older hypertension and diabetes). They will also collect all baseline study data, including baseline BP measurements.
The HBPM schedule that all participants will be asked to follow for the full 6-month study duration is HBPM using BP cuff or Lifelight® (depending on into which arm of the study they have been randomised) twice in a sitting for two sittings a day for one week every month. All participants will be asked to record their adherence to HBPM in the provided diary (recording the number of repeat measurements made on each day that those measurements are made and notes about any measurement failures). They will also be requested to record in their diary information about their healthcare resource use (GP appointments, outpatients' appointments, hospitalisations, medication and dose changes, medication adherence) and feedback about their HBPM method every month. All participants will also be asked to complete a set of tailored and validated questionnaires in the provided questionnaire booklet: quality of life.
The diaries and questionnaire booklets include instructions to assist with their accurate completion by participants. Participants will be issued with two diaries during their study participation: one at the baseline visit and one at the 3-month visit. They should complete the diary every day that they are doing HBPM. Participants will be issued with 3 questionnaire booklets during their study participation: two at the baseline visit and one at the 3-month visit. They should complete one questionnaire booklet within one week of their baseline visit, the second booklet within one week of their 3-month visit, and the third booklet within one week of their 6-month visit. Participants will be requested to bring back the diary and questionnaire booklet(s) at their subsequent study visit at BHT. Participants randomised to the Lifelight® arm will be prompted via the app to monitor their BP during the relevant weeks.
People eligible to take part in this study will be adults (18+ years old) with treated but uncontrolled hypertension. People with uncontrolled hypertension have the highest risk of CVD events and therefore the value of HBPM could be greatest for these people. The TASMIN and HOME BP studies focussed on this sub-population of patients with hypertension too, suggesting that future guidelines may continue to provide no recommendation of frequent HBPM for people with controlled hypertension, but a change to the guidelines for people with uncontrolled hypertension.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuff Arm | Active comparator | Device: Blood Pressure CuffBlood Pressure Cuff |
| LifeLight Arm | Experimental | Device: LifelightContactless Vital Signs Monitor using RPPG |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Established diagnosis of hypertension
- Uncontrolled hypertension defined as office blood pressure ≥140/90mmHg.
- Patients who are pharmacologically treated for their hypertension should have been on stable medication for at least 4 weeks.
- Ability to read, write and understand English to complete the study.
Key exclusion criteria (9 listed)
- Patients with stage III hypertension with office blood pressure ≥180/120mmHg or it is unsafe to keep them in the study, in the opinion of the investigators.
- Individuals with diagnosed atrial fibrillation.
- Patients with significant arrhythmias such as SVT (Supraventricular tachycardia) or any rhythm that has significant impact on their BP, poor perfusion, pregnancy, pre-eclampsia, deformities or abnormalities which may prevent proper application of a BP cuff, or skin disorders (anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria)
- Participants who are unwilling to undertake self-monitoring or lacking capacity.
- Partners or spouses of individuals already randomised in the trial
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 |
|---|---|---|
| LifelightContactless Vital Signs Measurement via RPPG | Device | LifeLight Arm |
| Blood Pressure CuffStandard Blood Pressure Cuff Digital | Device | Cuff Arm |
Primary outcome
Blood Pressure Measurement Non Inferiority
Time frame: 3 Months
Demonstrate non-inferiority of Lifelight® HBPM compared to cuff-based HBPM for achieving blood pressure control. (5 mmHg non-inferiority margin)
1 secondary outcome
Adherance to Blood Pressure Measurement
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifelight and Blood Pressure Cuff in people with Hypertension, run by Xim Limited 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence Pearce, BSc, MBA (07803950356, laurence@xim.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Measurement Non Inferiority (time frame: 3 Months). 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 3 Apr 2025.