Healthy AdultNCT07011407
The FACIAL Study Pilot
An observational study of Healthy Adult, run by Lancaster University at 1 site in United Kingdom.
Trial summary
Facial recognition is a non-invasive method for analysing facial characteristics and changes in facial expressions. There is evidence to suggest there may be a link between physiological health and facial expression patterns. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Maximal Exercise Test
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants from the general public, inlcuding students and staff from the university.
Who may be able to join
- Aged 18 to 35
- Male or female
- Capable of completing a maximal exercise test
- Answer "NO" to all variables in the Physical Activity Readiness questionnaire (PAR-Q)
Who cannot join
- Musculoskeletal injury
- Cardiovascular disease
- Neurological disease, stroke, or other disease that may affect facial expressions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Faculty of Health and Medicine, Lancaster University
Lancaster, Lancashire, LA1 4YW
Katie L Hoad, BSc, MSc, 07832158964 ext. 0044, k.hoad@lancaster.ac.uk
About this study
Official title: Facial Recognition in Acute Illness - The FACIAL Study
Facial recognition is a non-invasive method for analysing facial characteristics and changes in facial expressions. There is evidence to suggest there may be a link between physiological health and facial expression patterns. Many medical conditions are associated with specific facial characteristics, with some related to inherited genetic conditions and others that have been acquired as a result of medical conditions such as stroke, nerve injuries and dementia. If successful, this technology could prove useful for studies evaluating the monitoring of acute or chronic illness. The proposed study will ask participants to do a maximal exercise test that will challenge the body, as a proof-of-principle, to see how this correlates with facial expressions. Depending on the study outcomes and future work, it could prove to be a useful tool and clinical application in healthcare for evaluating and tracking patient health and well-being. The investigators want to conduct a proof-of-principle study where physically stressed young and healthy participants (in the form of a maximal exercise test), whilst recording facial expressions, will be used to determine the relationship between physiological stress and changes in facial parameters.
Read the detailed description
For this pilot study, no specific sample size calculation is required for this pilot study as this will recruit 15 participants for proof of concept. The outcomes from this research will lead to the identification of measurement parameters to be evaluated in future studies concerning facial characteristics and their parameters. This will inform the next steps in the application of the process to further healthy participants with the ultimate aim to translate this to research on a range of patient populations in elective and acute medical settings.
Video and still image capture will be undertaken using a camera mounted on a tripod in front of the participant whilst they are exercising. The data analysis mainly consists of four processing stages, including facial landmark detection, facial region identification, region-based facial analysis and data correlations, as illustrated in the diagram below. The facial landmark detection can label a total of 68 points in each face, which are in the predefined locations. Based on the facial landmark, the region identification can segment the face into different areas, such as brows, eyes, chin, etc. Then, the region-based analysis can be applied to facial data and extracts the geometry, colour, emotion and temperature information of the individual facial region and calculates their variations against time. Finally, vital sign reading and region-based facial data are analysed together by using statistical tools in order to identify their correlations and demonstrate how facial appearances change in different scenarios.
Lancaster University is the data owner/controller, and UCLAN will follow Lancaster's requirements of data management when the data is processed. The data will be transferred on an encrypted hard drive and stored on secure online storage by UCLAN data protection rules. The data will only be accessible to the FACIAL study collaborators and statisticians. Whilst sociodemographic and physiological data can be anonymised, the video recordings of facial expressions cannot. The two sets of data will be provided with separate research codes so that protected data cannot be linked to identities by anyone other than the study team. Processing of protected data such as ethnicity and biometric data is central to the research question and ultimately, might have efficacy in the treatment of high dependency patients in hospital care.
The FACIAL Study protocol has been formulated and reviewed by the FACIAL Steering Committee, and research will be carried out in line with the University of Central Lancashire and Lancaster University code of ethics. The FACIAL study will be carried out by the FACIAL steering committee as a collaboration between East Lancashire Hospitals NHS Trust, Lancaster University and the University of Central Lancashire.
The findings from this study will be presented at national or international conferences. Any facial images used for publication will be obtained with additional consent from the individuals. Manuscript(s) will be prepared for submission to a peer-reviewed journal.
- Conditions
- Healthy Adult
- Being tested
- Maximal Exercise Test
- Keywords
- Facial Characteristics, Exercise, Thermal Patterns, Facial Expression, Maximal Exercise Test
- Medical subject headings
- Motor Activity, Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal Exercise TestOther
Healthy participants will be situated on a cycle ergometer fitted with a 12-lead ECG or chest-strap heart rate monitor. Data from the questionnaire will be stored in a study site file in a locked cabinet in an office. Baseline readings will be obtained whilst on the bike for 3 minutes before the subject embarks on a 3-minute warm-up at 50 Watts (W). The workload (watts) on the bike is then increased to a workload that corresponds to a heart rate of 120 bpm (gentle exercise). The workload will then be increased by 25-50W every three minutes until volitional exhaustion. Between each stage, there will be a 30s rest period where the participant will be cycling with minimal resistance ("freewheeling") but will be otherwise stationary on the cycle ergometer. Still images of the face and facial video recordings will be taken during a 30s rest period between increases in exercise intensity. A finger-prick blood sample (glucose \& lactate) will be taken at the beginning and every 3 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distance between facial features
Change in inter-feature distance (e.g., between eyes, mouth corners) during different phases of exercise, captured using video and still images to detect facial regions and landmarks. Unit: millimetres (mm).
Measured: 60 minutes
Change in size and shape of facial features
Change in facial feature dimensions (e.g., width and height of eyes, mouth) and geometric shape indices during different phases of exercise. Additionally, captured using video and still images to detect facial regions and landmarks. Units: millimetres² or shape index (unitless).
Measured: 60 minutes
Change in facial blood flow patterns
Regional blood flow variation across facial regions during exercise, captured through thermal imaging. Unit: perfusion units or arbitrary units (a.u.)
Measured: 60 minutes
Change in facial temperature
Alterations in surface temperature across facial regions during exercise, measured with thermal imaging. Units: degrees Celsius (°C)
Measured: 60 minutes
Change in facial skin colour
Variation in facial colour intensity and hue across regions during exercise, analysed from captured video, thermal imaging and still images. Unit of measure: RGB values
Measured: 60 minutes
Secondary outcomes (4)
Change in heart rate
Heart rate is recorded at rest, during exercise, and during recovery. Units: Beats per minute (bpm)
Measured: 60 minutes
Change in heart rate variability (HRV)
Analysis of time and frequency domain HRV indices during different exercise stages. Units: Milliseconds (ms)
Measured: 60 minutes
Change in blood glucose
Blood glucose levels are recorded at rest, during exercise, and recovery. Unit: millimoles per litre (mmol/L)
Measured: 60 minutes
Change in Blood Lactate
Blood lactate recorded at rest, during exercise, and recovery. Units: millimoles per litre (mmol/L)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion12 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Lancashire, East Lancashire Hospitals NHS Trust
- Responsible party
- Principal investigator, Dr. Chris Gaffney, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011407
- Sponsor's protocol ID
- FHM-2024-4068-RECR-2
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This pilot study is a proof-of-principle study where we physically stress young, healthy participants (in the form of a maximal exercise test), whilst recording facial expressions, to determine the relationship between physiological stress and changes in facial parameters. The code developed from this pilot will be used as part of a PhD project at UCLan and is therefore novel. Individual participant data will not be shared externally at this time.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Recognition in Acute Illness - The FACIAL Study
- ClinicalTrials.gov ID
- NCT07011407
- Acronym / sponsor ID
- FHM-2024-4068-RECR-2
- Conditions
- Healthy Adult
- Keywords
- Facial Characteristics, Exercise, Thermal Patterns, Facial Expression, Maximal Exercise Test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Collaborators
- University of Central Lancashire, East Lancashire Hospitals NHS Trust
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 12 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jun 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.
Facial recognition is a non-invasive method for analysing facial characteristics and changes in facial expressions. There is evidence to suggest there may be a link between physiological health and facial expression patterns. Many medical conditions are associated with specific facial characteristics, with some related to inherited genetic conditions and others that have been acquired as a result of medical conditions such as stroke, nerve injuries and dementia. If successful, this technology could prove useful for studies evaluating the monitoring of acute or chronic illness. The proposed study will ask participants to do a maximal exercise test that will challenge the body, as a proof-of-principle, to see how this correlates with facial expressions. Depending on the study outcomes and future work, it could prove to be a useful tool and clinical application in healthcare for evaluating and tracking patient health and well-being. The investigators want to conduct a proof-of-principle study where physically stressed young and healthy participants (in the form of a maximal exercise test), whilst recording facial expressions, will be used to determine the relationship between physiological stress and changes in facial parameters.
Detailed description
For this pilot study, no specific sample size calculation is required for this pilot study as this will recruit 15 participants for proof of concept. The outcomes from this research will lead to the identification of measurement parameters to be evaluated in future studies concerning facial characteristics and their parameters. This will inform the next steps in the application of the process to further healthy participants with the ultimate aim to translate this to research on a range of patient populations in elective and acute medical settings.
Video and still image capture will be undertaken using a camera mounted on a tripod in front of the participant whilst they are exercising. The data analysis mainly consists of four processing stages, including facial landmark detection, facial region identification, region-based facial analysis and data correlations, as illustrated in the diagram below. The facial landmark detection can label a total of 68 points in each face, which are in the predefined locations. Based on the facial landmark, the region identification can segment the face into different areas, such as brows, eyes, chin, etc. Then, the region-based analysis can be applied to facial data and extracts the geometry, colour, emotion and temperature information of the individual facial region and calculates their variations against time. Finally, vital sign reading and region-based facial data are analysed together by using statistical tools in order to identify their correlations and demonstrate how facial appearances change in different scenarios.
Lancaster University is the data owner/controller, and UCLAN will follow Lancaster's requirements of data management when the data is processed. The data will be transferred on an encrypted hard drive and stored on secure online storage by UCLAN data protection rules. The data will only be accessible to the FACIAL study collaborators and statisticians. Whilst sociodemographic and physiological data can be anonymised, the video recordings of facial expressions cannot. The two sets of data will be provided with separate research codes so that protected data cannot be linked to identities by anyone other than the study team. Processing of protected data such as ethnicity and biometric data is central to the research question and ultimately, might have efficacy in the treatment of high dependency patients in hospital care.
The FACIAL Study protocol has been formulated and reviewed by the FACIAL Steering Committee, and research will be carried out in line with the University of Central Lancashire and Lancaster University code of ethics. The FACIAL study will be carried out by the FACIAL steering committee as a collaboration between East Lancashire Hospitals NHS Trust, Lancaster University and the University of Central Lancashire.
The findings from this study will be presented at national or international conferences. Any facial images used for publication will be obtained with additional consent from the individuals. Manuscript(s) will be prepared for submission to a peer-reviewed journal.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants from the general public, inlcuding students and staff from the university.
Key inclusion criteria (4 listed)
- Aged 18 to 35
- Male or female
- Capable of completing a maximal exercise test
- Answer "NO" to all variables in the Physical Activity Readiness questionnaire (PAR-Q)
Key exclusion criteria (3 listed)
- Musculoskeletal injury
- Cardiovascular disease
- Neurological disease, stroke, or other disease that may affect facial expressions
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 |
|---|---|---|
| Maximal Exercise TestHealthy participants will be situated on a cycle ergometer fitted with a 12-lead ECG or chest-strap heart rate monitor. Data from the questionnaire will be stored in a study site file in a locked cabinet in an office. Baseline readings will be obtained whilst on the bike for 3 minutes before the subject embarks on a 3-minute warm-up at 50 Watts (W). The workload (watts) on the bike is then increased to a workload that corresponds to a heart rate of 120 bpm (gentle exercise). The workload will then be increased by 25-50W every three minutes until volitional exhaustion. Between each stage, there will be a 30s rest period where the participant will be cycling with minimal resistance ("freewheeling") but will be otherwise stationary on the cycle ergometer. Still images of the face and facial video recordings will be taken during a 30s rest period between increases in exercise intensity. A finger-prick blood sample (glucose \& lactate) will be taken at the beginning and every 3 minutes. | Other | – |
Primary outcome
Change in distance between facial features
Time frame: 60 minutes
Change in inter-feature distance (e.g., between eyes, mouth corners) during different phases of exercise, captured using video and still images to detect facial regions and landmarks. Unit: millimetres (mm).
Change in size and shape of facial features
Time frame: 60 minutes
Change in facial feature dimensions (e.g., width and height of eyes, mouth) and geometric shape indices during different phases of exercise. Additionally, captured using video and still images to detect facial regions and landmarks. Units: millimetres² or shape index (unitless).
Change in facial blood flow patterns
Time frame: 60 minutes
Regional blood flow variation across facial regions during exercise, captured through thermal imaging. Unit: perfusion units or arbitrary units (a.u.)
Change in facial temperature
Time frame: 60 minutes
Alterations in surface temperature across facial regions during exercise, measured with thermal imaging. Units: degrees Celsius (°C)
Change in facial skin colour
Time frame: 60 minutes
Variation in facial colour intensity and hue across regions during exercise, analysed from captured video, thermal imaging and still images. Unit of measure: RGB values
4 secondary outcomes
Change in heart rate
Time frame: 60 minutes
Change in heart rate variability (HRV)
Time frame: 60 minutes
Change in blood glucose
Time frame: 60 minutes
Change in Blood Lactate
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No. This pilot study is a proof-of-principle study where we physically stress young, healthy participants (in the form of a maximal exercise test), whilst recording facial expressions, to determine the relationship between physiological stress and changes in facial parameters. The code developed from this pilot will be used as part of a PhD project at UCLan and is therefore novel. Individual participant data will not be shared externally at this time.
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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.
Faculty of Health and Medicine, Lancaster University
Lancaster, United Kingdom
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 Healthy Adult, run by Lancaster University 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distance between facial features (time frame: 60 minutes). 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 8 Jun 2025.