Fudan Tinnitus Doctor for Tinnitus Management

May 4, 2026 updated by: Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, two-arm, parallel-group, open-label randomized controlled trial designed to evaluate the efficacy, usability, and safety of a multi-agent large language model (LLM)-based conversational artificial intelligence system (Fudan Tinnitus Doctor, FTD) for the management of chronic subjective tinnitus.

A total of 256 participants will be randomized in a 1:1 ratio to either the FTD intervention or a non-conversational digital education control. The intervention period is 30 days. The FTD system delivers personalized, real-time tinnitus management using a multi-agent architecture integrating cognitive behavioral therapy (CBT)-based strategies, including psychoeducation, cognitive restructuring, relaxation training, and sleep hygiene guidance. The control group receives a static digital program consisting of educational materials and a fixed-response question-and-answer module.

The primary outcome will be the change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI) from baseline to Day 30. Secondary outcomes will include sleep quality (Pittsburgh Sleep Quality Index, PSQI), anxiety (GAD-2), depression (PHQ-2), and overall perceived improvement (Patient Global Impression of Change, PGIC). Exploratory outcomes will assess usability (System Usability Scale, SUS), satisfaction (Net Promoter Score, NPS), and engagement metrics. All outcomes will be analyzed using mixed-effects models under the intention-to-treat principle.

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200031
        • Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FTD Conversational AI Intervention
Participants in this arm will use the Fudan Tinnitus Doctor (FTD) system, a multi-agent large language model-based conversational AI platform that delivers personalized tinnitus management strategies based on cognitive behavioral therapy principles.
Device: 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.
Active Comparator: Digital Education Control
Participants in this arm will receive access to a non-conversational digital program consisting of static educational materials and a fixed-response question-and-answer module related to tinnitus, sleep, and mental health.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: 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).
Baseline, Day 14, and Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-2 (PHQ-2)
Time Frame: Baseline, Day 14, and Day 30
The PHQ-2 will measure depressive symptoms over the past two weeks. Each of the two items is rated from 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 6, with higher scores indicating greater depressive symptoms. A score ≥3 suggests clinically significant depression.
Baseline, Day 14, and Day 30
Patient Global Impression of Change (PGIC)
Time Frame: Day 14, and Day 30
The PGIC will assess the participant's overall perception of improvement since starting the intervention. It is rated on a 7-point Likert scale from 1 ("very much improved") to 7 ("very much worse"), with lower scores representing greater perceived improvement.
Day 14, and Day 30
Generalized Anxiety Disorder Scale (GAD-2)
Time Frame: Baseline, Day 14, and Day 30]
The GAD-2 will assess anxiety symptoms over the past two weeks. Each of the two items is rated from 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 6, with higher scores indicating greater anxiety. A score ≥3 suggests clinically significant anxiety.
Baseline, Day 14, and Day 30]
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, Day 14, and Day 30
The PSQI will be used to evaluate subjective sleep quality over the past month. It comprises 19 items yielding seven component scores (subjective sleep quality, latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction). The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Baseline, Day 14, and Day 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net Promoter Score (NPS)
Time Frame: Day 30
The Net Promoter Score (NPS) will be used to assess participants' likelihood of recommending the Fudan Tinnitus Doctor system to others at Day 30. Participants will rate their likelihood on a scale from 0 (not at all likely) to 10 (extremely likely).
Day 30
System Usability Scale (SUS)
Time Frame: Day 30
The System Usability Scale (SUS) will be used to evaluate participants' perceived usability and satisfaction with the Fudan Tinnitus Doctor (FTD) conversational AI system at Day 30. The SUS is a 10-item questionnaire rated on a 5- point scale. The total score will be calculated as (sum of adjusted item scores × 2.5), ranging from 0 to 100, with higher scores indicating greater usability.
Day 30
User Engagement Metrics
Time Frame: Continuous during 30-day intervention period

User engagement will be assessed using three predefined system-recorded metrics:

(1)Login Frequency: Number of logins. (2)Active Session Duration: Total time (minutes) spent actively interacting with the system, excluding inactive periods and time spent completing study assessments. (3)Conversation Turns: Number of complete interaction cycles, defined as one user input followed by one system response.

Higher values indicate greater engagement.
Continuous during 30-day intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Shan Sun, Eye and ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified individual participant data (IPD) collected for this trial, including outcome measures and baseline characteristics, will be made available upon reasonable request to qualified researchers. Data sharing will require prior approval from the Institutional Review Board of the Eye & ENT Hospital of Fudan University. The DeepSeek-R1 671B model used to support the intervention is open-source and publicly accessible at https://github.com/deepseek-ai/DeepSeek-R1.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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