HypertensionNCT06535152
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
A study testing Lifelight and Manual sphygmomanometer in people with Hypertension, run by Xim Limited at 1 site in United States.
Trial summary
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard smartphone or tablet camera. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Lifelight and Manual sphygmomanometer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to 3 Aug 2023
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged 18 to 85 years old
Who cannot join
- Participants were excluded from the study if they were medically unsuitable for participation at time of visit, any heart dysrhythmias (except respiratory sinus arrhythmia) as confirmed with a 3 lead ECG, compromised circulation or peripheral vascular disease, clotting disorders, female participants who were pregnant or trying to get pregnant, excessive facial hair, and conditions that affect the skin, such as anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria.
- Participants could choose to withdraw themselves from the study without prejudice or they could be withdrawn by study investigators for predetermined reasons. Data excluded from the analysis was documented with justifications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
Official title: CLINIMARK Clinical Investigation Plan Lifelight Non-Invasive Blood Pressure Validation Study PR 2021-443
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard smartphone or tablet camera.
By conducting this validation study we aimed to demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive and demonstrate its accuracy for measuring pulse rate and the blood pressure of people with blood pressures relevant to Stage 1 hypertension.
Read the detailed description
Lifelight was investigated in a study that followed the data collection and data analysis methodology outlined in ISO 81060-2:2018/AMD 1:2020 "Non-invasive Sphygmomanometers - Part 2: Clinical investigation of automated measurement type". This validation study was conducted by independent laboratory Element Materials Technology Boulder (formerly Clinimark), a global leader for clinical testing of vital sign data for medical devices and consumer wearable products. The study generated data from 85 people aged 18-85 with the wide-ranging distribution of blood pressures specified in ISO 81060-2:2018/AMD 1:2020.The accuracy of Lifelight's blood pressure measurements was assessed by comparing Lifelight's measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of Lifelight's pulse rate measurements was assessed by comparing Lifelight's measurements with concurrent ECG-derived heart rate values. Data was collected in an Independent Review Board-approved study conducted by independent laboratory Clinimark (now Element) in the USA and repurposed for the testing of the new improved model in the latest version of the Lifelight® EA device. The data collected consists of 85 participants, with three readings each. The participants were resting before their measurements were taken to ensure stable blood pressure. For each Lifelight measurement, two sets of blood pressure measurements were taken using dual-observer manual auscultation. The first measurement was taken before the Lifelight measurement and the second just after. If there was too much variation between the before and after measurement, or between the two independent observers, the measurement was discarded and repeated. For this validation procedure, the measurements taken during the original study were re-processed in the new updated algorithm.
- Conditions
- Hypertension
- Being tested
- Lifelight, Manual sphygmomanometer
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifelightDevice
Lifelight is a artificial-intelligence software application that enables completely contactless spot measurements (i.e., one-off measurements without prior calibration) of PR and BP. Based on the science of remote photoplethysmography (rPPG), Lifelight works by detecting tiny changes in the colour of facial skin that occur every time the heart beats. All that is required to generate PR and BP measurements is that the software application is downloaded onto a computer device (e.g., smartphone or tablet) with a standard camera, and that the patient's face stays in the line of sight of the camera for up to 60 seconds.
Manual sphygmomanometerDevice
Blood Pressure Measurement
| Study group | Role | What they receive |
|---|---|---|
| Lifelight and BP measurement | Experimental | The accuracy of Lifelight's blood pressure measurements was assessed by comparing Lifelight's measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of Lifelight's pulse rate measurements was assessed by comparing Lifelight's measurements with concurrent ECG-derived heart rate values. The participants were resting before their measurements were taken to ensure stable blood pressure. For each Lifelight measurement, two sets of blood pressure measurements were taken using dual-observer manual auscultation. The first measurement was taken before the Lifelight measurement and the second just after. If there was too much variation between the before and after measurement, or between the 2 independent observers, the measurement was discarded and repeated. For this validation procedure, the measurements taken during the original study were re-processed in the new updated algorithm. Receives: Device: Lifelight; Device: Manual sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Classification Accuracy
Demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive.
Measured: Up to 3 Months
Pulse Rate Measurement Accuracy (relevant to Stage 1 hypertension
Demonstrate its accuracy for measuring pulse rate (bpm)
Measured: Up to 3 Months
Blood Pressure Measurement Accuracy (relevant to Stage 1 hypertension
the blood pressure (mmHg) of people with blood pressures relevant to Stage 1 hypertension
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start18 May 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Up to eight pairs of reference and Lifelight recordings (starting and ending with reference recordings) were taken sequentially to obtain a minimum of three valid paired reference and Lifelight BP measurements. At least 60 seconds elapsed between each BP determination.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xim Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Element Materials Technology, Mind Over Matter Medtech Ltd
- Responsible party
- Sponsor
- Investigators
- Arthur Cabrera, MD, Principal investigator, Investigator has left Element Materials Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535152
- Sponsor's protocol ID
- PR 2021-443
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINIMARK Clinical Investigation Plan Lifelight Non-Invasive Blood Pressure Validation Study PR 2021-443
- ClinicalTrials.gov ID
- NCT06535152
- Acronym / sponsor ID
- PR 2021-443
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Xim LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Element Materials Technology, Mind Over Matter Medtech Ltd
- Study start
- 18 May 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 2 Aug 2024 (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.
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard smartphone or tablet camera.
By conducting this validation study we aimed to demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive and demonstrate its accuracy for measuring pulse rate and the blood pressure of people with blood pressures relevant to Stage 1 hypertension.
Detailed description
Lifelight was investigated in a study that followed the data collection and data analysis methodology outlined in ISO 81060-2:2018/AMD 1:2020 "Non-invasive Sphygmomanometers - Part 2: Clinical investigation of automated measurement type". This validation study was conducted by independent laboratory Element Materials Technology Boulder (formerly Clinimark), a global leader for clinical testing of vital sign data for medical devices and consumer wearable products. The study generated data from 85 people aged 18-85 with the wide-ranging distribution of blood pressures specified in ISO 81060-2:2018/AMD 1:2020.The accuracy of Lifelight's blood pressure measurements was assessed by comparing Lifelight's measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of Lifelight's pulse rate measurements was assessed by comparing Lifelight's measurements with concurrent ECG-derived heart rate values. Data was collected in an Independent Review Board-approved study conducted by independent laboratory Clinimark (now Element) in the USA and repurposed for the testing of the new improved model in the latest version of the Lifelight® EA device. The data collected consists of 85 participants, with three readings each. The participants were resting before their measurements were taken to ensure stable blood pressure. For each Lifelight measurement, two sets of blood pressure measurements were taken using dual-observer manual auscultation. The first measurement was taken before the Lifelight measurement and the second just after. If there was too much variation between the before and after measurement, or between the two independent observers, the measurement was discarded and repeated. For this validation procedure, the measurements taken during the original study were re-processed in the new updated algorithm.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to eight pairs of reference and Lifelight recordings (starting and ending with reference recordings) were taken sequentially to obtain a minimum of three valid paired reference and Lifelight BP measurements. At least 60 seconds elapsed between each BP determination.
| Arm | Type | Receives |
|---|---|---|
| Lifelight and BP measurement | Experimental | Device: Lifelight, Device: Manual sphygmomanometerThe accuracy of Lifelight's blood pressure measurements was assessed by comparing Lifelight's measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of Lifelight's pulse rate measurements was assessed by comparing Lifelight's measurements with concurrent ECG-derived heart rate values. The participants were resting before their measurements were taken to ensure stable blood pressure. For each Lifelight measurement, two sets of blood pressure measurements were taken using dual-observer manual auscultation. The first measurement was taken before the Lifelight measurement and the second just after. If there was too much variation between the before and after measurement, or between the 2 independent observers, the measurement was discarded and repeated. For this validation procedure, the measurements taken during the original study were re-processed in the new updated algorithm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers aged 18 to 85 years old
Key exclusion criteria (2 listed)
- Participants were excluded from the study if they were medically unsuitable for participation at time of visit, any heart dysrhythmias (except respiratory sinus arrhythmia) as confirmed with a 3 lead ECG, compromised circulation or peripheral vascular disease, clotting disorders, female participants who were pregnant or trying to get pregnant, excessive facial hair, and conditions that affect the skin, such as anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria.
- Participants could choose to withdraw themselves from the study without prejudice or they could be withdrawn by study investigators for predetermined reasons. Data excluded from the analysis was documented with justifications.
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 |
|---|---|---|
| LifelightLifelight is a artificial-intelligence software application that enables completely contactless spot measurements (i.e., one-off measurements without prior calibration) of PR and BP. Based on the science of remote photoplethysmography (rPPG), Lifelight works by detecting tiny changes in the colour of facial skin that occur every time the heart beats. All that is required to generate PR and BP measurements is that the software application is downloaded onto a computer device (e.g., smartphone or tablet) with a standard camera, and that the patient's face stays in the line of sight of the camera for up to 60 seconds. | Device | Lifelight and BP measurement |
| Manual sphygmomanometerBlood Pressure Measurement | Device | Lifelight and BP measurement |
Primary outcome
Blood Pressure Classification Accuracy
Time frame: Up to 3 Months
Demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive.
Pulse Rate Measurement Accuracy (relevant to Stage 1 hypertension
Time frame: Up to 3 Months
Demonstrate its accuracy for measuring pulse rate (bpm)
Blood Pressure Measurement Accuracy (relevant to Stage 1 hypertension
Time frame: Up to 3 Months
the blood pressure (mmHg) of people with blood pressures relevant to Stage 1 hypertension
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 2 Aug 2024.
- Contactless and Calibration-free Blood Pressure and Pulse Rate Monitor for Screening and Monitoring of Hypertension: Cross-sectional Validation StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Arthur Cabrera, MD principal investigator
Investigator has left Element Materials Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifelight and Manual sphygmomanometer in people with Hypertension, run by Xim Limited at 1 site in United States.
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 1 inclusion and 2 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 2 Aug 2024. 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 States. 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 Classification Accuracy (time frame: Up to 3 Months). The study lists 3 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 2 Aug 2024.