Vital Sign Comparison Between Lifelight and Standard of Care - Development

NCT ID: NCT04003662

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients and volunteers both with and without medical problems will be recruited; vital sign measurements are taken twice with normal equipment and while recording video data at the same time. The data collected will allow the Artificial Intelligence to develop the LifeLight algorithm to to improve measurement accuracy of its video data based vital signs monitor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Vital signs such as heart rate, blood pressure, breathing rate and oxygen levels currently need several pieces of equipment and trained staff in order to be measured properly. The LifeLight app measures the same vital signs using a camera in a phone, tablet, laptop or smart TV. By using very small changes in the colour of your skin, LifeLight's AI system can calculate these values without any extra equipment or training, and without contact.

The aim of this research study is to improve the accuracy of the LifeLight system with a view to a subsequent Validation study to prove the level of accuracy. The investigators will recruit patients, staff and visitors, both with and without medical problems, and take vital sign measurements twice with normal equipment and while recording video data at the same time. This will allow the AI which develops the LifeLight algorithm to make it more accurate, prior to a subsequent study which will validate the results.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vital Signs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

inpatients

Vital signs measurement - standard of care and prototype

Vital Signs Measurement

Intervention Type DEVICE

Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

outpatients

Vital signs measurement - standard of care and prototype

Vital Signs Measurement

Intervention Type DEVICE

Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Healthy controls

Vital signs measurement - standard of care and prototype

Vital Signs Measurement

Intervention Type DEVICE

Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vital Signs Measurement

Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* I1. Sufficiently conversant in the English language to satisfy I3.
* I2. Able and willing to comply with all study requirements.
* I3. Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xim Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Portsmouth Hospitals NHS Trust

Portsmouth, England, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHT/2018/25 IRAS ID 242581

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ClearSight System CHN Study
NCT03807622 COMPLETED
Home Monitoring Study for Surgical Patients
NCT07231653 NOT_YET_RECRUITING
Vis-Rx Post-Market Evaluation
NCT04533503 COMPLETED