Heart RateNCT05889832
Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Remote Photoplethysmography
A study testing measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops) in people with Heart Rate and Heart Rate Variability, run by SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce at 1 site in Poland.
Trial summary
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability and breathing rate measurement with the use of Shen.AI Vitals software developed by MX Labs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, Heart Rate Variability, Respiratory Rate
- What is being tested?
- measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePoland
- Study dates
- 26 Apr 2023to 6 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- ability to read and write in Polish or English
- ability to operate a smartphone, tablet and laptop without the need for glasses
- ability to understand the study procedure
- ability to communicate and follow the instructions of the study staff
- written consent to participate in the study and to the processing of personal data by the research team and the sponsor of the study
Who cannot join
- failure to provide the required information in the participant's information survey
- failure to comply with the study procedure or the instructions of the study stuff
- extensive facial skin damage (including abrasions, wounds, burns)
- a disease process involving a large part of the face that makes the video- based measurement impossible
- extensive face dressing
- extensive facial skin tattoo or face painting
Show all 13Show fewer
- marked deformation of the face (e.g. a tumor)
- inability to keep the head stable in the required position during the measurement
- persistent cough making it impossible to remain still during the measurement
- respiratory dysfunction in the form of shortness of breath or irregular or shallow breathing
- diagnosed arrhythmia (except sinus bradycardia or tachycardia)
- moderate or severe anemia
- diagnosed: heart failure, left ventricular systolic dysfunction, aortic stenosis or other diseases or disorders within the heart vascular system leading to decreased stroke volume, low pressure amplitude or the so-called paradoxical pulse
Trial locations and contacts
1 site in 1 country.
Poland1 site
Uniwersyteckie Centrum Wsparcia Badań Klinicznych we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Official title: Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Vitals Software.
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability and breathing rate measurement with the use of Shen.AI Vitals software developed by MX Labs.
Read the detailed description
Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software).
The measurements will be taken with various camera-equipped devices (smartphones, tablets, laptops) using either front camera (self-measurement) or rear camera (measurement made by someone else), in two different lighting conditions (artificial light or natural daylight), with various levels of device stability (fully stable or held in hand/s), and in two different body positions (sitting or supine). In total, each participant will have 8 measurements taken.
Standard deviation of normal heartbeat intervals (SDNN) will be used as the main HRV index.
Apart from the average HR (averaged over the whole 1-minute measurement), instantaneous values of HR (averaged over 10 s) will also be determined and displayed every 1 s by the Shen.AI VItals software.
In all cases, reference measurements will be taken simultaneously (chest ECG for the calculation of average and instantaneous HR as well as HRV; impedance pneumography for the determination of BR).
The reference measurements will be taken with Finapres Nova with the ECG+Resp module (Finapres Medical Systems B.V.).
For each measured parameter, the results from both methods will be compared using the Bland-Altman analysis or non-parametric limits of agreement.
- Conditions
- Heart Rate, Heart Rate Variability, Respiratory Rate
- Being tested
- measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)Diagnostic test
Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software).
Reference measurements will be taken simultaneously (chest ECG for the calculation of HR and HRV; impedance pneumography for BR).
| Study group | Role | What they receive |
|---|---|---|
| HR, HRV and BR measured with Shen.AI and reference method | Experimental | Not described Receives: Diagnostic Test: measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of heart rate (HR) measurement with the software under test compared with the ECG-based measurement
In each participant, average HR will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device.
The results from both methods will be compared using non-parametric limits of agreement.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of heart rate variability index (SDNN) measurement with the software under test compared with the ECG-based measurement
In each participant, the standard deviation of normal heartbeat intervals (SDNN) will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of breathing rate (BR) measurement with the software under test compared with the impedance pneumography-based measurement
In each participant, the breathing rate will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded impedance pneumography signal. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of instantaneous heart rate measurement with the software under test compared with the ECG-based measurement
In each participant, multiple instantaneous heart rate values (averaged over 10 s) will be estimated from the software under test and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device.
The results from both methods will be compared using non-parametric limits of agreement.
Measured: day 1 (single visit, approximately 30 minutes)
Secondary outcomes (14)
Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held by someone else (compared with reference measurements).
Each participant will have one video-based measurement performed with the software under test on a smartphone held by someone else (facial video measurement of HR using the rear camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using non-parametric limits of agreement.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held by someone else (compared with reference measurements).
Each participant will have one video-based measurement performed with the software under test on a smartphone held by someone else (facial video measurement of SDNN using the rear camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held by someone else (compared with reference measurements).
Each participant will have one video-based measurement performed with the software under test on a smartphone held by someone else (facial video measurement of BR using the rear camera).
For reference, BR will be obtained from the simultaneously recorded impedance pneumography signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held in hand/s (compared with reference measurements).
Each participant will have one video measurement performed with the software under test on a smartphone held in hand/s (facial video measurement of HR using the rear camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using non-parametric limits of agreement.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held in hand/s (compared with reference measurements).
Each participant will have one video measurement performed with the software under test on a smartphone held in hand/s (facial video measurement of SDNN using the rear camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held in hand/s (compared with reference measurements).
Each participant will have one video measurement performed with the software under test on a smartphone held in hand/s (facial video measurement of BR using the rear camera).
For reference, BR will be obtained from the simultaneously recorded impedance pneumography signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate (HR) with the software under test in daylight conditions (compared with reference measurements).
Each participant will have one facial video measurement performed in daylight conditions (1-minute measurement of HR using the front smartphone camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using non-parametric limits of agreement.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in daylight conditions (compared with reference measurements).
Each participant will have one facial video measurement performed in daylight conditions (1-minute measurement of SDNN using the front smartphone camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of breathing rate (BR) with the software under test in daylight conditions (compared with reference measurements).
Each participant will have one facial video measurement performed in daylight conditions (1-minute measurement of BR using the front smartphone camera).
For reference, BR will be obtained from the simultaneously recorded impedance pneumography signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate (HR) with the software under test in the supine position (compared with reference measurements).
Each participant will have one facial video measurement performed in the supine position (1-minute measurement of HR using the front smartphone camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using non-parametric limits of agreement.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in the supine position (compared with reference measurements).
Each participant will have one facial video measurement performed in the supine position (1-minute measurement of SDNN using the front smartphone camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement breathing rate (BR) with the software under test in the supine position (compared with reference measurements).
Each participant will have one facial video measurement performed in the supine position (1-minute measurement of BR using the front smartphone camera).
For reference BR will be obtained from the simultaneously recorded impedance pneumography signal.
The results from both methods will be compared using the Bland-Altman analysis.
Measured: day 1 (single visit, approximately 30 minutes)
Utility of the software under test for self-measurement of physiological parameters (assessed with a questionnaire).
The utility of the software under test for self-measurement of physiological parameters (HR, SDNN, and BR) will be assessed based on of the average score in the participant's questionnaire completed by each participant after the test procedure (i.e. after all measurements in the given participant).
The scale will be 1-5, with higher scores meaning better outcome.
Measured: day 1 (after a single visit, approximately 30 minutes)
Utility of the software under test for the measurement of someone's physiological parameters (assessed with a questionnaire).
The utility of the software under test for the video-based measurement of someone's physiological parameters will be assessed based on the average score in the participant's questionnaire (the part of the questionnaire related to the measurement with the rear camera of a smartphone) completed by each participant after the test procedure(i.e. after all measurements in the given participant).
The scale will be 1-5, with higher scores meaning better outcome.
Measured: day 1 (after a single visit, approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start26 Apr 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bartłomiej Paleczny, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889832
- Sponsor's protocol ID
- MDF-01-008-01
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Vitals Software.
- ClinicalTrials.gov ID
- NCT05889832
- Acronym / sponsor ID
- MDF-01-008-01
- Conditions
- Heart Rate, Heart Rate Variability, Respiratory Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w PolsceIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 5 Jun 2023 (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.
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability and breathing rate measurement with the use of Shen.AI Vitals software developed by MX Labs.
Detailed description
Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software).
The measurements will be taken with various camera-equipped devices (smartphones, tablets, laptops) using either front camera (self-measurement) or rear camera (measurement made by someone else), in two different lighting conditions (artificial light or natural daylight), with various levels of device stability (fully stable or held in hand/s), and in two different body positions (sitting or supine). In total, each participant will have 8 measurements taken.
Standard deviation of normal heartbeat intervals (SDNN) will be used as the main HRV index.
Apart from the average HR (averaged over the whole 1-minute measurement), instantaneous values of HR (averaged over 10 s) will also be determined and displayed every 1 s by the Shen.AI VItals software.
In all cases, reference measurements will be taken simultaneously (chest ECG for the calculation of average and instantaneous HR as well as HRV; impedance pneumography for the determination of BR).
The reference measurements will be taken with Finapres Nova with the ECG+Resp module (Finapres Medical Systems B.V.).
For each measured parameter, the results from both methods will be compared using the Bland-Altman analysis or non-parametric limits of agreement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR, HRV and BR measured with Shen.AI and reference method | Experimental | Diagnostic Test: measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- ability to read and write in Polish or English
- ability to operate a smartphone, tablet and laptop without the need for glasses
- ability to understand the study procedure
- ability to communicate and follow the instructions of the study staff
Key exclusion criteria (13 listed)
- failure to provide the required information in the participant's information survey
- failure to comply with the study procedure or the instructions of the study stuff
- extensive facial skin damage (including abrasions, wounds, burns)
- a disease process involving a large part of the face that makes the video- based measurement impossible
- extensive face dressing
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 |
|---|---|---|
| measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software). Reference measurements will be taken simultaneously (chest ECG for the calculation of HR and HRV; impedance pneumography for BR). | Diagnostic test | HR, HRV and BR measured with Shen.AI and reference method |
Primary outcome
Accuracy of heart rate (HR) measurement with the software under test compared with the ECG-based measurement
Time frame: day 1 (single visit, approximately 30 minutes)
In each participant, average HR will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using non-parametric limits of agreement.
Accuracy of heart rate variability index (SDNN) measurement with the software under test compared with the ECG-based measurement
Time frame: day 1 (single visit, approximately 30 minutes)
In each participant, the standard deviation of normal heartbeat intervals (SDNN) will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using the Bland-Altman analysis.
Accuracy of breathing rate (BR) measurement with the software under test compared with the impedance pneumography-based measurement
Time frame: day 1 (single visit, approximately 30 minutes)
In each participant, the breathing rate will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded impedance pneumography signal. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using the Bland-Altman analysis.
Accuracy of instantaneous heart rate measurement with the software under test compared with the ECG-based measurement
Time frame: day 1 (single visit, approximately 30 minutes)
In each participant, multiple instantaneous heart rate values (averaged over 10 s) will be estimated from the software under test and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using non-parametric limits of agreement.
14 secondary outcomes
Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held by someone else (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held by someone else (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held by someone else (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held in hand/s (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held in hand/s (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held in hand/s (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate (HR) with the software under test in daylight conditions (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in daylight conditions (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of breathing rate (BR) with the software under test in daylight conditions (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate (HR) with the software under test in the supine position (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in the supine position (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Accuracy of measurement breathing rate (BR) with the software under test in the supine position (compared with reference measurements).
Time frame: day 1 (single visit, approximately 30 minutes)
Utility of the software under test for self-measurement of physiological parameters (assessed with a questionnaire).
Time frame: day 1 (after a single visit, approximately 30 minutes)
Utility of the software under test for the measurement of someone's physiological parameters (assessed with a questionnaire).
Time frame: day 1 (after a single visit, approximately 30 minutes)
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 28 Mar 2024.
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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.
Bartłomiej Paleczny principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops) in people with Heart Rate and Heart Rate Variability, run by SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce at 1 site in Poland.
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 6 inclusion and 13 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 28 Mar 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 Poland. 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?
Accuracy of heart rate (HR) measurement with the software under test compared with the ECG-based measurement (time frame: day 1 (single visit, approximately 30 minutes)). 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 28 Mar 2024.