Evaluating a Contactless Monitor for Blood Pressure at Home
VISION-Real World Evaluation
This study is testing whether a new contactless blood pressure monitor works as well as traditional cuffs for people with high blood pressure who are managing their condition at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Xim Limited Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06325384 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness of a contactless vital signs monitor, Lifelight®, with traditional blood pressure cuffs for home monitoring in patients with uncontrolled hypertension. Participants aged 18 and older will be recruited from hypertension clinics and randomly assigned to use either the Lifelight® device or a standard BP cuff. Over six months, they will record their blood pressure readings and adherence to the monitoring schedule, while also tracking healthcare resource use and feedback on their monitoring method. The study aims to assess the feasibility and clinical outcomes of these two monitoring approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of uncontrolled hypertension.
Not a fit: Patients with stage III hypertension or significant arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more convenient and effective method for patients to monitor their blood pressure at home.
How similar studies have performed: Other studies have shown promise in using innovative monitoring technologies for hypertension management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Patients on active cancer treatment * Terminally ill patients * Patients who cannot tolerate sitting for up to one hour.
Where this trial is running
London
- William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square, — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Laurence Pearce, BSc, MBA
- Email: laurence@xim.ai
- Phone: 07803950356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.