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NCT07558837

Fudan Tinnitus Doctor for Tinnitus Management: A Randomized Controlled Trial

Sponsor: Eye & ENT Hospital of Fudan University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate whether a conversational artificial intelligence-based digital intervention can improve symptoms in adults with chronic subjective tinnitus. The main questions it aims to answer are: Does the Fudan Tinnitus Doctor (FTD) system reduce tinnitus severity as measured by the Tinnitus Handicap Inventory (THI). Does the FTD system improve sleep quality, anxiety, depression, and overall patient-reported outcomes. Researchers will compare the FTD system to a non-conversational digital education program to determine whether the AI-based intervention provides greater clinical benefits. Participants will: Use either the FTD conversational AI system or a static digital education program for 30 days. Complete standardized questionnaires assessing tinnitus severity, sleep, mood, and overall improvement at baseline, Day 14, and Day 30. Engage with the digital platform for tinnitus self-management.

Official title: A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2026-05-01

Completion Date

2027-05-30

Last Updated

2026-04-30

Healthy Volunteers

Conditions

Tinnitus

Interventions

OTHER

Fudan Tinnitus Doctor (FTD) System

The FTD system is a conversational AI platform that provides real-time, personalized tinnitus management through multimodal interaction (text and voice). It integrates a large language model, retrieval-augmented generation, and multi-agent collaboration to deliver CBT-based interventions, including psychoeducation, cognitive restructuring, relaxation techniques, and sleep hygiene guidance.

OTHER

Non-conversational Digital Education Program

This intervention includes structured educational articles and a predefined Q\&A module. It does not provide personalized or interactive conversational support.

Inclusion Criteria: 1. Diagnosis of subjective tinnitus confirmed by a qualified investigator. 2. Tinnitus duration ≥ 3 month prior to screening. 3. THI score of ≥ 18 4. Aged between 18 and 70 years 5. The ability to use a smartphone: Both groups will receive therapeutic support and disease management primarily through a mobile application or web-based platform. This requires functional ability to operate the provided software and willingness to engage with the digital intervention protocol. 6. Perceptibility: Tinnitus is present and recognizable by the participant under ordinary daily conditions (not only in quiet environments). 7. Compliance and consent: Participant is assessed by the Investigator as able to understand study procedures, voluntarily agrees to participate, is willing to comply with all trial-related requirements, and provides signed informed consent prior to performance of any protocol-specified procedure. Exclusion Criteria: 1. Acute-phase tinnitus (duration \< 3 month or tinnitus secondary to acute otologic events). 2. Pulsatile or objective tinnitus. 3. Unstable symptoms: Fluctuating tinnitus loudness at screening or baseline. 4. Psychiatric contraindication: History or current presence of severe psychiatric disorders (e.g., major depressive disorder with recent suicidality, schizophrenia) that, in the opinion of the Investigator, may interfere with study participation or data validity. 5. Testing limitations: Inability to adequately complete tinnitus testing procedures or comply with study assessments. 6. Prior therapy exposure: Previous history of sound therapy specifically for tinnitus management. 7. Concurrent treatments: Ongoing psychotherapy for conditions such as anxiety or depression, or any other psychological treatment that may interfere with the study endpoints. 8. Concurrent trial participation: Active participation in another interventional research study that, in the opinion of the Investigator, could affect tinnitus symptoms or interact with study procedures. 9. Investigator judgment: Any condition (medical, surgical, psychiatric, or social) or factor which, in the Investigator's judgment, renders the subject unsuitable for participation, places the patient at higher risk, or may interfere with compliance or scientific validity of the trial.

Locations (1)

Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department

Shanghai, China