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OpenTrials
Completed

NCT Number: NCT04003662

Vital Sign Comparison Between Lifelight and Standard of Care - Development

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.

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Key information

Conditions

Vital Signs

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, England, PO6 3LY, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vital Signs Measurement

Device

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

Primary outcomes

  1. Blood Pressure Readings

    Time frame: Single Visit; up to one day

    Comparison of digital video data to standard of care measurement

  2. Oxygen Saturation Readings

    Time frame: Single Visit; up to one day

    Comparison of digital video data to standard of care measurement

  3. Heart Rate (pulse) Readings

    Time frame: Single Visit; up to one day

    Comparison of digital video data to standard of care measurement

  4. Respiratory Rate

    Time frame: Single Visit; up to one day

    Comparison of digital video data to standard of care measurement

Sponsors and collaborators

Lead sponsor

Xim Limited

Industry

Registry information

Acronym: VISION-D

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2019
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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