Fudan Tinnitus Doctor for Tinnitus Management

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.

NCT Number	NCT07558837
Lead Sponsor	Eye & ENT Hospital of Fudan University
Conditions	Tinnitus
Enrollment	256 participants
Start Date	2026-05-01
Primary Completion	2027-05-30 (estimated)
Study Completion	2027-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-07