NCT06325384

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

January 24, 2024

Last Update Submit

March 28, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 Months

Secondary Outcomes (1)

  • Adherance to Blood Pressure Measurement

    6 Months

Study Arms (2)

Cuff Arm

ACTIVE COMPARATOR

Blood Pressure Cuff

Device: Blood Pressure Cuff

LifeLight Arm

EXPERIMENTAL

Contactless Vital Signs Monitor using RPPG

Device: Lifelight

Interventions

LifelightDEVICE

Contactless Vital Signs Measurement via RPPG

LifeLight Arm
Blood Pressure CuffDEVICE

Standard Blood Pressure Cuff Digital

Cuff Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square,

London, EC1M 6BQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Laurence Pearce, BSc, MBA

CONTACT

07803950356laurence@xim.ai

Gauri Misra, BDS, MSc.

CONTACT

07880228126gauri.misra@xim.ai

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

March 22, 2024

Study Start

February 10, 2025

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations

GB(1)