Vital Sign Comparison Between Lifelight and Standard of Care - Development (VISION-D)

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.

Study Overview

• Status: Completed
• Conditions: Vital Signs
• Intervention / Treatment: Device: Vital Signs Measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 9000

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Portsmouth, England, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The inclusion/exclusion criteria is limited to the proposed intended use of the device, therefore only individuals, of any sex, over the age of 3 will be included in the study.

Description

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).

Exclusion Criteria:

• There are no exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
inpatients; Vital signs measurement - standard of care and prototype	Device: Vital Signs Measurement; 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	Device: Vital Signs Measurement; 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	Device: Vital Signs Measurement; Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Readings	Comparison of digital video data to standard of care measurement	Single Visit; up to one day
Oxygen Saturation Readings	Comparison of digital video data to standard of care measurement	Single Visit; up to one day
Heart Rate (pulse) Readings	Comparison of digital video data to standard of care measurement	Single Visit; up to one day
Respiratory Rate	Comparison of digital video data to standard of care measurement	Single Visit; up to one day

Collaborators and Investigators

• Sponsor: Xim Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PHT/2018/25 IRAS ID 242581

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No