Health TrialsbyHealthPanel

Fudan Tinnitus Doctor for Tinnitus Management

ConditionTinnitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of subjective tinnitus confirmed by a qualified investigator.

Tinnitus duration ≥ 3 month prior to screening.

THI score of ≥ 18

Aged between 18 and 70 years

Disqualifiers

Acute-phase tinnitus (duration < 3 month or tinnitus secondary to acute otologic events).

Pulsatile or objective tinnitus.

Unstable symptoms: Fluctuating tinnitus loudness at screening or baseline.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fudan Tinnitus Doctor (FTD) System

    Device

    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

    Device

    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.

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: FTD Conversational AI InterventionExperimental treatment 1 intervention
Group B: Digital Education ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tinnitus Handicap Inventory (THI)

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).

Time frame
Baseline, Day 14, and Day 30

Secondary outcomes

1

Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame
Baseline, Day 14, and Day 30
2

Generalized Anxiety Disorder Scale (GAD-2)

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.

Time frame
Baseline, Day 14, and Day 30]
3

Patient Health Questionnaire-2 (PHQ-2)

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.

Time frame
Baseline, Day 14, and Day 30
4

Patient Global Impression of Change (PGIC)

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.

Time frame
Day 14, and Day 30

Other outcomes

1

System Usability Scale (SUS)

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.

Time frame
Day 30
2

Net Promoter Score (NPS)

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).

Time frame
Day 30
3

User Engagement Metrics

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.

Time frame
Continuous during 30-day intervention period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov

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