Vital SignsVISION-DNCT04003662
Vital Sign Comparison Between Lifelight and Standard of Care - Development
An observational study of Vital Signs, run by Xim Limited at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Vital Signs
- What is being tested?
- Vital Signs Measurement
- Type of treatment
- Medical device
- How many people
- 9,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, England, PO6 3LY
About this study
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.
Read the 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.
- Conditions
- Vital Signs
- Being tested
- Vital Signs Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Signs MeasurementDevice
Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.
| Study group | Role | What they receive |
|---|---|---|
| inpatients | Vital signs measurement - standard of care and prototype Receives: Device: Vital Signs Measurement | |
| outpatients | Vital signs measurement - standard of care and prototype Receives: Device: Vital Signs Measurement | |
| Healthy controls | Vital signs measurement - standard of care and prototype Receives: Device: Vital Signs Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Readings
Comparison of digital video data to standard of care measurement
Measured: Single Visit; up to one day
Oxygen Saturation Readings
Comparison of digital video data to standard of care measurement
Measured: Single Visit; up to one day
Heart Rate (pulse) Readings
Comparison of digital video data to standard of care measurement
Measured: Single Visit; up to one day
Respiratory Rate
Comparison of digital video data to standard of care measurement
Measured: Single Visit; up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 May 2018
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xim Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003662
- Sponsor's protocol ID
- PHT/2018/25 IRAS ID 242581
- Acronym
- VISION-D
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Sign Comparison Between Lifelight and Standard of Care - Development
- ClinicalTrials.gov ID
- NCT04003662
- Acronym / sponsor ID
- VISION-D / PHT/2018/25 IRAS ID 242581
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Xim LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inpatients | – | Device: Vital Signs MeasurementVital signs measurement - standard of care and prototype |
| outpatients | – | Device: Vital Signs MeasurementVital signs measurement - standard of care and prototype |
| Healthy controls | – | Device: Vital Signs MeasurementVital signs measurement - standard of care and prototype |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vital Signs MeasurementVital signs are measured twice with standard of care equipment while recording digital video data at the same time. | Device | Healthy controls, inpatients, outpatients |
Primary outcome
Blood Pressure Readings
Time frame: Single Visit; up to one day
Comparison of digital video data to standard of care measurement
Oxygen Saturation Readings
Time frame: Single Visit; up to one day
Comparison of digital video data to standard of care measurement
Heart Rate (pulse) Readings
Time frame: Single Visit; up to one day
Comparison of digital video data to standard of care measurement
Respiratory Rate
Time frame: Single Visit; up to one day
Comparison of digital video data to standard of care measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Xim Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Readings (time frame: Single Visit; up to one day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.