NCT06325384 Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
| NCT ID | NCT06325384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xim Limited |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-02-10 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06325384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06325384 currently recruiting?
Yes, NCT06325384 is actively recruiting participants. Contact the research team at laurence@xim.ai for enrollment information.
Where is the NCT06325384 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06325384 clinical trial?
NCT06325384 is sponsored by Xim Limited. The trial plans to enroll 500 participants.