NCT06325384Recruiting
Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
VISION-Real World Evaluation
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 24 Jan 2024
- Start date
- 10 Feb 2025
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Xim Limited
- Diseases
- High blood pressure
- NCT number
- NCT06325384
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 10 Feb 2025 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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)
- Patients on dialysis or known ESRD (End-stage kidney disease)
- Patients on active cancer treatment
Other
- Individuals with diagnosed atrial fibrillation.
- Participants who are unwilling to undertake self-monitoring or lacking capacity.
- Partners or spouses of individuals already randomised in the trial
- Terminally ill patients
- Patients who cannot tolerate sitting for up to one hour.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square, Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.