NCT06474923

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

June 14, 2024

Last Update Submit

September 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 minutes

Study Arms (2)

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.

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.

Behavioral: Face image and voice audio

Interventions

Take photographs of the front, left and right side of the patient's face. Recording the patient's voice during doctor-patient communication.

AR patientNon-AR patient

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Initial clinical diagnosis of chronic rhinitis, able to perform a basic examination, cooperate with face photography and voice capture

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, China

Location

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Zheng Liu, Doctor

    Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 26, 2024

Study Start

June 1, 2024

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations