Heart RateNCT06829615
Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography
A study testing Shen.AI in people with Heart Rate and Heart Rate Variability, run by SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce at 2 sites in Poland.
Trial summary
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability, breathing rate and blood pressure measurement with the use of Shen.AI software. 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, Breathing Rate
- What is being tested?
- Shen.AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesPoland
- Study dates
- 6 May 2025to 3 Oct 2025
- 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 mobile device and a laptop without requiring glasses
- Ability to understand the study procedure
- Ability to communicate and follow instructions from the study personnel
- Provision of written informed consent for participation in the study and for the processing of personal data by the research team and the study sponsor
- Blood pressure values in accordance with the distribution of the study group
Who cannot join
- Pregnancy
- Age below 18 years
- Failure to provide the required information in the participant's informational questionnaire
- Non-compliance with the study procedure or instructions from the study personnel
- Extensive facial skin damage (e.g., abrasions, wounds, burns)
- A disease process affecting a significant portion of the face
Show all 18Show fewer
- Extensive facial dressing
- Extensive facial tattoos or facial painting
- Significant facial deformity (e.g., tumor)
- Inability to maintain a stable head position during measurement
- Persistent cough preventing stillness during measurement
- Respiratory dysfunction such as dyspnea, irregular or shallow breathing
- Diagnosed arrhythmia (except for sinus bradycardia or sinus tachycardia)
- Moderate or severe anemia
- Diagnosed conditions such as left ventricular systolic dysfunction, aortic valve stenosis, or other cardiac or circulatory diseases leading to low stroke volume, low pulse amplitude, or pulsus paradoxus
- Implanted cardiac pacemaker
- Blood pressure difference between arms exceeding 15 mmHg for systolic pressure or 10 mmHg for diastolic pressure
- Inability to determine blood pressure in both arms
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
OVO MEDICAL Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 50-414
Przychodnia rehabilitacyjna R-MED
Wroclaw, Lower Silesian Voivodeship, 53-033
About this study
Official title: Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Software
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability, breathing rate and blood pressure measurement with the use of Shen.AI software.
Read the detailed description
The primary objective of this clinical study is to assess the accuracy of heart rate (HR), heart rate variability (HRV), breathing rate (BR), and blood pressure (BP) measurements obtained using Shen.AI software as the investigational device under its intended conditions of use, enabling users to obtain reliable information about their physiological state. These conditions include measurements taken at rest, in a home-like environment, with participants independently operating a mobile device or laptop equipped with a camera.
Physiological parameters, including HR, HRV, BR, and BP, will be measured and estimated using remote photoplethysmography (rPPG) based on a 1-minute facial video analysis processed by Shen.AI software.
Throughout all measurements, participants will be connected to a reference device that records ECG while simultaneously measuring chest impedance (impedance pneumography). Additionally, each participant will wear a respiratory belt transducer. Depending on the measurement type, the participant's blood pressure will be assessed using either an auscultatory or an automatic blood pressure monitor. The study will be conducted on a diverse group of participants, varying in blood pressure, gender, age, skin phototype, and BMI.
For each measured parameter, results obtained from both methods will be compared using Bland-Altman analysis or non-parametric limits of agreement.
- Conditions
- Heart Rate, Heart Rate Variability, Breathing Rate, Blood Pressure
- Being tested
- Shen.AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen.AIDevice
Contactless measurement of heart rate, heart rate variability, breathing rate, and blood pressure using Shen.AI software and reference methods.
| Study group | Role | What they receive |
|---|---|---|
| HR, HRV, BR, and BP measured using Shen.AI and reference methods | Experimental | Not described Receives: Device: Shen.AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the average heart rate (HR) measurement using the device under test compared to the reference measurement.
Average HR will be estimated using Shen.AI software and compared with simultaneously recorded ECG .
Measured: One appointment (day 1)
Accuracy of the measurement of the heart rate variability index - Standard Deviation of Normal-to-Normal intervals (SDNN) using the device under test compared to the reference measurement.
The heart rate variability index (SDNN) will be measured using Shen.AI software and compared with the simultaneously recorded ECG.
Measured: One appointment (day 1)
Accuracy of the breathing rate (BR) measurement using the device under test compared to the reference measurement.
Average BR will be estimated using Shen.AI software and compared with the recorded impedance pneumography signal in the absence of read-out capability supported by the respiratory belt transducer.
Measured: One appointment (day 1)
Accuracy of systolic and diastolic blood pressure (BP) measurements using the device under test in relation to the reference measurement.
Average BP will be estimated using Shen.AI software and compared with auscultatory blood pressure measurements.
Measured: One appointment (day 1)
Accuracy of systolic and diastolic blood pressure (BP) measurement using the device under test, taking into account the calibration of the BP measurement function, in relation to the reference measurement.
Average BP will be estimated using Shen.AI software and compared with auscultatory blood pressure measurements. Measurements will be performed during two visits, with the second visit occurring 14 ± 3 days apart.
Measured: Two appointments (14 ± 3 days apart)
Secondary outcomes (3)
Accuracy of the measurement of other heart rate variability metrics - Root Mean Square of Successive Differences (RMSSD) using the device under test.
The heart rate variability index (RMSSD) will be measured using Shen.AI software and compared with the simultaneously recorded ECG.
Measured: One appointment (day 1)
Accuracy of blood oxygen saturation measurement using the device under test
The blood oxygen saturation will be measured using Shen.AI software and compared with the simultaneously obtained blood oxygen measurements.
Measured: One appointment (day 1)
Accuracy of Body Mass Index (BMI) estimation using the device under test.
The BMI will be measured using Shen.AI software and compared with the values obtained from a weight scale and stadiometer.
Measured: One appointment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start6 May 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
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
- 132 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
- Justyna Chojdak-Łukasiewicz, MD, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829615
- Sponsor's protocol ID
- MDF-01-008-03
- Status last verified
- Nov 2025
- First submitted
- 10 Feb 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Software
- ClinicalTrials.gov ID
- NCT06829615
- Acronym / sponsor ID
- MDF-01-008-03
- Conditions
- Heart Rate, Heart Rate Variability, Breathing Rate, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w PolsceIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 17 Feb 2025 (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, breathing rate and blood pressure measurement with the use of Shen.AI software.
Detailed description
The primary objective of this clinical study is to assess the accuracy of heart rate (HR), heart rate variability (HRV), breathing rate (BR), and blood pressure (BP) measurements obtained using Shen.AI software as the investigational device under its intended conditions of use, enabling users to obtain reliable information about their physiological state. These conditions include measurements taken at rest, in a home-like environment, with participants independently operating a mobile device or laptop equipped with a camera.
Physiological parameters, including HR, HRV, BR, and BP, will be measured and estimated using remote photoplethysmography (rPPG) based on a 1-minute facial video analysis processed by Shen.AI software.
Throughout all measurements, participants will be connected to a reference device that records ECG while simultaneously measuring chest impedance (impedance pneumography). Additionally, each participant will wear a respiratory belt transducer. Depending on the measurement type, the participant's blood pressure will be assessed using either an auscultatory or an automatic blood pressure monitor. The study will be conducted on a diverse group of participants, varying in blood pressure, gender, age, skin phototype, and BMI.
For each measured parameter, results obtained from both methods will be compared using 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, BR, and BP measured using Shen.AI and reference methods | Experimental | Device: Shen.AI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Ability to read and write in Polish or English
- Ability to operate a mobile device and a laptop without requiring glasses
- Ability to understand the study procedure
- Ability to communicate and follow instructions from the study personnel
Key exclusion criteria (18 listed)
- Pregnancy
- Age below 18 years
- Failure to provide the required information in the participant's informational questionnaire
- Non-compliance with the study procedure or instructions from the study personnel
- Extensive facial skin damage (e.g., abrasions, wounds, burns)
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 |
|---|---|---|
| Shen.AIContactless measurement of heart rate, heart rate variability, breathing rate, and blood pressure using Shen.AI software and reference methods. | Device | HR, HRV, BR, and BP measured using Shen.AI and reference methods |
Primary outcome
Accuracy of the average heart rate (HR) measurement using the device under test compared to the reference measurement.
Time frame: One appointment (day 1)
Average HR will be estimated using Shen.AI software and compared with simultaneously recorded ECG .
Accuracy of the measurement of the heart rate variability index - Standard Deviation of Normal-to-Normal intervals (SDNN) using the device under test compared to the reference measurement.
Time frame: One appointment (day 1)
The heart rate variability index (SDNN) will be measured using Shen.AI software and compared with the simultaneously recorded ECG.
Accuracy of the breathing rate (BR) measurement using the device under test compared to the reference measurement.
Time frame: One appointment (day 1)
Average BR will be estimated using Shen.AI software and compared with the recorded impedance pneumography signal in the absence of read-out capability supported by the respiratory belt transducer.
Accuracy of systolic and diastolic blood pressure (BP) measurements using the device under test in relation to the reference measurement.
Time frame: One appointment (day 1)
Average BP will be estimated using Shen.AI software and compared with auscultatory blood pressure measurements.
Accuracy of systolic and diastolic blood pressure (BP) measurement using the device under test, taking into account the calibration of the BP measurement function, in relation to the reference measurement.
Time frame: Two appointments (14 ± 3 days apart)
Average BP will be estimated using Shen.AI software and compared with auscultatory blood pressure measurements. Measurements will be performed during two visits, with the second visit occurring 14 ± 3 days apart.
3 secondary outcomes
Accuracy of the measurement of other heart rate variability metrics - Root Mean Square of Successive Differences (RMSSD) using the device under test.
Time frame: One appointment (day 1)
Accuracy of blood oxygen saturation measurement using the device under test
Time frame: One appointment (day 1)
Accuracy of Body Mass Index (BMI) estimation using the device under test.
Time frame: One appointment (day 1)
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 18 Nov 2025.
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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.
Justyna Chojdak-Łukasiewicz, MD, PhD principal investigator
Wroclaw Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shen.AI in people with Heart Rate and Heart Rate Variability, run by SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce at 2 sites 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 7 inclusion and 18 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 the average heart rate (HR) measurement using the device under test compared to the reference measurement. (time frame: One appointment (day 1)). The study lists 5 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 18 Nov 2025.