Fudan Tinnitus Doctor (FTD) SystemNon-conversational Digital Education Program
Fudan Tinnitus Doctor (FTD) System: The FTD system is a multi-agent conversational artificial intelligence platform that delivers personalized tinnitus management through a secure web-based interface. It supports multimodal interaction (text and voice) and integrates a large language model, retrieval-augmented generation, and multi-agent collaboration to provide cognitive behavioral therapy-based interventions, including psychoeducation, cognitive restructuring, relaxation techniques, and sleep hygiene guidance.
Non-conversational Digital Education Program: Participants in this arm will receive access to a non-conversational digital tinnitus self-management program delivered through the same secure web-based interface as the intervention group. The program provides static educational materials and a fixed-response question-and-answer module related to tinnitus, sleep, and mental health.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Tinnitus Handicap Inventory (THI) — Baseline, Day 14, and Day 30 The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Trial sites (1)
Facility
City
Region
Status
Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
Shanghai
China
More Eye & ENT Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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