Body ImageNCT06474923
Multimodal Data-assisted Primary Screening for Allergic Rhinitis Based on Voice Recognition and Face Recognition
An observational study of Body Image and Speech Sound Disorder, run by Zheng Liu at 1 site in China.
Trial summary
Collect facial images and voice and audio of patients with rhinitis in the department of otolaryngology, and collect the examination results of patients with rhinitis who have received electronic fiber nasopharyngoscopy. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Body Image, Speech Sound Disorder
- What is being tested?
- Face image and voice audio
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2025
- How long will I take part?
- 3 Months
- 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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Initial clinical diagnosis of chronic rhinitis, able to perform a basic examination, cooperate with face photography and voice capture
Who may be able to join
- Subjects understood the purpose and procedure of the trial and signed an informed consent form, and voluntarily participated in this study;
- Subjects were initially clinically diagnosed with chronic rhinitis;
- Subjects were aged 8-80 years old, limited to Chinese nationality, and were able to perform basic examinations and cooperate with face photography and voice collection.
Who cannot join
- Those who received systemic immunotherapy, used systemic or local glucocorticoids as well as leukotriene receptor antagonists within one month;
- Those who suffer from immune system diseases, autoimmune diseases, allergic diseases or allergies and have a history of food allergy;
- Other serious systemic diseases, such as active tuberculosis, rheumatic heart disease, congenital heart disease, arthritis, nephritis, hypertension, psychosis, dermatitis, epilepsy and so on;
- Women during lactation and pregnancy;
- History of upper respiratory tract infection or more serious infectious diseases within three months;
- Those who are currently participating in another clinical study or have participated in another clinical study within 90 days;
- Other patients who, in the judgment of the clinician, are not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Affiliation: Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Multimodal Data-assisted Primary Screening for Allergic Rhinitis Based on Voice Recognition and Face
Collect facial images and voice and audio of patients with rhinitis in the department of otolaryngology, and collect the examination results of patients with rhinitis who have received electronic fiber nasopharyngoscopy. Skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test for detecting immunoglobulin E antibodies against various common inhalant allergenswere detected, and a prediction model for the type of rhinitis was finally established.
Read the detailed description
The incidence of allergic rhinitis is high and the progression of the disease is serious, but public awareness of the disease is limited. Mistaking allergic rhinitis for the common cold or other respiratory illnesses and purchasing non-specific medications for its treatment not only delays proper diagnosis and treatment, but may also lead to further aggravation of the disease and complications. Such omission, misdiagnosis and mistreatment of allergic rhinitis not only affects the management and control of the disease, but may also result in unnecessary wastage of healthcare resources and increased treatment costs.
In this study, the investigators propose to capture face photographs and audio files of rhinitis patients coming to the otolaryngology clinic using a work cell phone to determine whether the patients are allergic or non-allergic rhinitis by using an allergy detection test. The face photos, audio files and basic clinical information were multimodally fused to construct a prediction model, and the effectiveness of the model was evaluated.
Ultimately, it is expected that the predictive model can simply identify and screen for allergic rhinitis, improve public awareness and understanding of allergic rhinitis, and take proper treatment measures.
- Conditions
- Body Image, Speech Sound Disorder
- Being tested
- Face image and voice audio
- Medical subject headings
- Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face image and voice audioBehavioural
Take photographs of the front, left and right side of the patient's face. Recording the patient's voice during doctor-patient communication.
| Study group | Role | What they receive |
|---|---|---|
| AR patient | Diagnosis was made by inhalant allergen screening and blood-serology specific IgE test results according to ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines. Clinical symptoms include sneezing, runny nose, itchy nose, and pale edema of bilateral inferior turbinate when exposed to specific allergens. Receives: Behavioral: Face image and voice audio | |
| Non-AR patient | The final diagnosis of non-allergic rhinitis was made based on the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and exclusion by inhalant allergen screening and blood-serology specific IgE test results. Receives: Behavioral: Face image and voice audio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen Test Results
Atopic status was evaluated by skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test (Phadia, Uppsala, Sweden) for detecting immunoglobulin E antibodies against various common inhalant allergens. Allergic rhinitis was diagnosed in patients with a positive skin prick or positive blood IgE.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zheng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Liu, Huazhong University of Science and Technology
- Investigators
- Zheng Liu, Doctor, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474923
- Sponsor's protocol ID
- Stent-002
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Data-assisted Primary Screening for Allergic Rhinitis Based on Voice Recognition and Face
- ClinicalTrials.gov ID
- NCT06474923
- Acronym / sponsor ID
- Stent-002
- Conditions
- Body Image, Speech Sound Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Zheng LiuUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Jun 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.
Collect facial images and voice and audio of patients with rhinitis in the department of otolaryngology, and collect the examination results of patients with rhinitis who have received electronic fiber nasopharyngoscopy. Skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test for detecting immunoglobulin E antibodies against various common inhalant allergenswere detected, and a prediction model for the type of rhinitis was finally established.
Detailed description
The incidence of allergic rhinitis is high and the progression of the disease is serious, but public awareness of the disease is limited. Mistaking allergic rhinitis for the common cold or other respiratory illnesses and purchasing non-specific medications for its treatment not only delays proper diagnosis and treatment, but may also lead to further aggravation of the disease and complications. Such omission, misdiagnosis and mistreatment of allergic rhinitis not only affects the management and control of the disease, but may also result in unnecessary wastage of healthcare resources and increased treatment costs.
In this study, the investigators propose to capture face photographs and audio files of rhinitis patients coming to the otolaryngology clinic using a work cell phone to determine whether the patients are allergic or non-allergic rhinitis by using an allergy detection test. The face photos, audio files and basic clinical information were multimodally fused to construct a prediction model, and the effectiveness of the model was evaluated.
Ultimately, it is expected that the predictive model can simply identify and screen for allergic rhinitis, improve public awareness and understanding of allergic rhinitis, and take proper treatment measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR patient | – | Behavioral: Face image and voice audioDiagnosis was made by inhalant allergen screening and blood-serology specific IgE test results according to ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines. Clinical symptoms include sneezing, runny nose, itchy nose, and pale edema of bilateral inferior turbinate when exposed to specific allergens. |
| Non-AR patient | – | Behavioral: Face image and voice audioThe final diagnosis of non-allergic rhinitis was made based on the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and exclusion by inhalant allergen screening and blood-serology specific IgE test results. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Initial clinical diagnosis of chronic rhinitis, able to perform a basic examination, cooperate with face photography and voice capture
Key inclusion criteria (3 listed)
- Subjects understood the purpose and procedure of the trial and signed an informed consent form, and voluntarily participated in this study;
- Subjects were initially clinically diagnosed with chronic rhinitis;
- Subjects were aged 8-80 years old, limited to Chinese nationality, and were able to perform basic examinations and cooperate with face photography and voice collection.
Key exclusion criteria (7 listed)
- Those who received systemic immunotherapy, used systemic or local glucocorticoids as well as leukotriene receptor antagonists within one month;
- Those who suffer from immune system diseases, autoimmune diseases, allergic diseases or allergies and have a history of food allergy;
- Other serious systemic diseases, such as active tuberculosis, rheumatic heart disease, congenital heart disease, arthritis, nephritis, hypertension, psychosis, dermatitis, epilepsy and so on;
- Women during lactation and pregnancy;
- History of upper respiratory tract infection or more serious infectious diseases within three months;
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 |
|---|---|---|
| Face image and voice audioTake photographs of the front, left and right side of the patient's face. Recording the patient's voice during doctor-patient communication. | Behavioural | AR patient, Non-AR patient |
Primary outcome
Allergen Test Results
Time frame: 30 minutes
Atopic status was evaluated by skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test (Phadia, Uppsala, Sweden) for detecting immunoglobulin E antibodies against various common inhalant allergens. Allergic rhinitis was diagnosed in patients with a positive skin prick or positive blood IgE.
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 16 Sep 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.
Zheng Liu, Doctor study director
Tongji Hospital
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 Body Image and Speech Sound Disorder, run by Zheng Liu at 1 site in China.
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 3 inclusion and 7 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 16 Sep 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 China. 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?
Allergen Test Results (time frame: 30 minutes). 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 16 Sep 2025.