Anxiety DisordersML_AcuTongueNCT06899490
"Machine Learning Analysis of Lingual Colorimetry and MADRS Anxiety-Depression Score in Acupuncture Patients"
An observational study of Anxiety Disorders, run by Dr Benoit Bataille at 1 site in France.
Trial summary
This observational study aims to assess the potential relationship between tongue colorimetry (using standardized photographic techniques) and anxiety-depression scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) in acupuncture patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- How many people
- 466 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective observational monocentric study conducted in an acupuncture practice. The study aims to establish a correlation between tongue colorimetric features and MADRS scores in patients consulting for symptoms related to anxiety. Tongue photography and MADRS assessment present no risk to participants. A non-opposition declaration for photography and consent for anonymous and confidential data analysis will be obtained.
Who may be able to join
- Patients aged 18 years or older
- Native French speakers
- No medical conditions or medications affecting tongue coloration
- Consulting for acupuncture with symptoms involving an anxious component
Who cannot join
- Presence of psychosis or substance abuse
- Eating or taking medication within one hour before the examination
- Refusal to complete the Montgomery-Åsberg Depression Rating Scale (MADRS) questionnaire
- Refusal to have their tongue photographed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Machine Learning Analysis of Lingual Colorimetry and MADRS Score in Acupuncture Patients: A Prospective Observational Study
This observational study aims to assess the potential relationship between tongue colorimetry (using standardized photographic techniques) and anxiety-depression scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) in acupuncture patients. Data will be analyzed using machine learning methods to determine whether tongue color features correlate with MADRS scores, possibly contributing to a novel, non-invasive diagnostic tool for anxiety and depression assessment in clinical practice.
Participation involves only tongue photography and completion of questionnaires, without any invasive procedures or treatment modifications.
Read the detailed description
This prospective observational study investigates the correlation between lingual colorimetry, captured using readily available and standardized modern photographic tools (iPhone cameras), and anxiety-depression scores evaluated by the Montgomery-Åsberg Depression Rating Scale (MADRS) among patients attending routine acupuncture consultations.
Participants will undergo a simple and non-invasive photographic recording of their tongue using an iPhone, ensuring consistent lighting and standardized positioning to minimize variability. Simultaneously, participants will complete the MADRS questionnaire, a widely validated instrument for assessing anxiety and depression severity. No invasive procedures or therapeutic interventions beyond their usual acupuncture care will be performed.
The acquired photographic data will be analyzed using machine learning algorithms to identify potential predictive relationships between distinct colorimetric characteristics of the tongue and the MADRS scores. The objective is to determine whether lingual imaging could serve as a reliable, non-invasive biomarker or complementary diagnostic tool for assessing psychological status in clinical practice.
This approach leverages everyday technology (smartphones), promoting ease of replication and broader accessibility in clinical environments. Ultimately, findings from this study could facilitate early detection and monitoring of anxiety-depressive disorders, thus enhancing individualized patient care in complementary and integrative medicine.
- Conditions
- Anxiety Disorders
- Keywords
- Tongue Colorimetry, MADRS, Depression, Anxiety, Machine Learning, Acupuncture, Artificial Intelligence, Image Analysis
- Medical subject headings
- Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation using Machine Learning between Tongue Colorimetric Features and MADRS Scores
This study aims to evaluate the correlation between standardized tongue colorimetric parameters (obtained through digital photographs) and depression/anxiety scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Machine learning methods will be used to analyze tongue images and identify potential associations between colorimetric features and MADRS scores. Participants will be categorized into two subgroups: MADRS < 15 and MADRS ≥ 15, to assess the ability of tongue characteristics to differentiate depression severity.
Measured: Baseline (single evaluation at enrollment)
Secondary outcomes (1)
Machine Learning Analysis of Tongue Features and MADRS Scores
- Density Diagram.
- Partial Correlation Analysis (Train/Test Split): Relationship between tongue color and MADRS scores.
- Logistic Regression Model (Train/Test)
- Support Vector Machine (SVM) on PCA: Model performance evaluation with ROC analysis.
- Deep Learning Model: CNN applied to tongue images, classification based on color and texture.
- Shapley Values Interpretation: Feature importance analysis for AI models.
- Correlation Between Individual MADRS Items and Tongue Zones: Zone-by-zone statistical analysis.
- MANCOVA Analysis: Multivariate analysis of covariance to assess multiple dependent variables.
- CNN-based Model on Images: Direct classification of tongue features using convolutional neural networks.
- Subgroup Identification via PCA (3 Components): Exploring potential depression subtypes.
Measured: Baseline (single evaluation at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start27 Jun 2024
- Primary completion1 Nov 2025
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Benoit Bataille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Benoit Bataille, Centre Hospitalier de Narbonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899490
- Sponsor's protocol ID
- ML_AcuTongue_MADRS_01
- Acronym
- ML_AcuTongue
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The potential sharing of IPD is currently undecided due to ethical considerations regarding the anonymization of tongue photographs. The ethics committee has highlighted the importance of ensuring that no identifiable characteristics can be traced back to participants. If a sharing plan is implemented, it will ensure strict anonymization protocols, including removing metadata, blurring any identifiable features, and restricting access to approved researchers under a confidentiality agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Analysis of Lingual Colorimetry and MADRS Score in Acupuncture Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06899490
- Acronym / sponsor ID
- ML_AcuTongue / ML_AcuTongue_MADRS_01
- Conditions
- Anxiety Disorders
- Keywords
- Tongue Colorimetry, MADRS, Depression, Anxiety, Machine Learning, Acupuncture, Artificial Intelligence, Image Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Dr Benoit BatailleUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 28 Mar 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.
This observational study aims to assess the potential relationship between tongue colorimetry (using standardized photographic techniques) and anxiety-depression scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) in acupuncture patients. Data will be analyzed using machine learning methods to determine whether tongue color features correlate with MADRS scores, possibly contributing to a novel, non-invasive diagnostic tool for anxiety and depression assessment in clinical practice.
Participation involves only tongue photography and completion of questionnaires, without any invasive procedures or treatment modifications.
Detailed description
This prospective observational study investigates the correlation between lingual colorimetry, captured using readily available and standardized modern photographic tools (iPhone cameras), and anxiety-depression scores evaluated by the Montgomery-Åsberg Depression Rating Scale (MADRS) among patients attending routine acupuncture consultations.
Participants will undergo a simple and non-invasive photographic recording of their tongue using an iPhone, ensuring consistent lighting and standardized positioning to minimize variability. Simultaneously, participants will complete the MADRS questionnaire, a widely validated instrument for assessing anxiety and depression severity. No invasive procedures or therapeutic interventions beyond their usual acupuncture care will be performed.
The acquired photographic data will be analyzed using machine learning algorithms to identify potential predictive relationships between distinct colorimetric characteristics of the tongue and the MADRS scores. The objective is to determine whether lingual imaging could serve as a reliable, non-invasive biomarker or complementary diagnostic tool for assessing psychological status in clinical practice.
This approach leverages everyday technology (smartphones), promoting ease of replication and broader accessibility in clinical environments. Ultimately, findings from this study could facilitate early detection and monitoring of anxiety-depressive disorders, thus enhancing individualized patient care in complementary and integrative medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational monocentric study conducted in an acupuncture practice. The study aims to establish a correlation between tongue colorimetric features and MADRS scores in patients consulting for symptoms related to anxiety. Tongue photography and MADRS assessment present no risk to participants. A non-opposition declaration for photography and consent for anonymous and confidential data analysis will be obtained.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Native French speakers
- No medical conditions or medications affecting tongue coloration
- Consulting for acupuncture with symptoms involving an anxious component
Key exclusion criteria (4 listed)
- Presence of psychosis or substance abuse
- Eating or taking medication within one hour before the examination
- Refusal to complete the Montgomery-Åsberg Depression Rating Scale (MADRS) questionnaire
- Refusal to have their tongue photographed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation using Machine Learning between Tongue Colorimetric Features and MADRS Scores
Time frame: Baseline (single evaluation at enrollment)
This study aims to evaluate the correlation between standardized tongue colorimetric parameters (obtained through digital photographs) and depression/anxiety scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Machine learning methods will be used to analyze tongue images and identify potential associations between colorimetric features and MADRS scores. Participants will be categorized into two subgroups: MADRS < 15 and MADRS ≥ 15, to assess the ability of tongue characteristics to differentiate depression severity.
1 secondary outcome
Machine Learning Analysis of Tongue Features and MADRS Scores
Time frame: Baseline (single evaluation at enrollment)
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 21 Oct 2026.
- Individual participant dataSharing planned: Undecided. The potential sharing of IPD is currently undecided due to ethical considerations regarding the anonymization of tongue photographs. The ethics committee has highlighted the importance of ensuring that no identifiable characteristics can be traced back to participants. If a sharing plan is implemented, it will ensure strict anonymization protocols, including removing metadata, blurring any identifiable features, and restricting access to approved researchers under a confidentiality agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders, run by Dr Benoit Bataille at 1 site in France.
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 4 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 21 Oct 2026. 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 France. 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?
Correlation using Machine Learning between Tongue Colorimetric Features and MADRS Scores (time frame: Baseline (single evaluation at enrollment)). 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 21 Oct 2026.