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
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
Treatments tested in this trial
- Fudan Tinnitus Doctor (FTD) System
- Non-conversational Digital Education Program
Treatment groups
256 Participants
are divided into 2 treatment groupsLocations
1Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department200031, Shanghai China
Sponsors and collaborators
Eye & ENT Hospital of Fudan University
Lead sponsor
Source ClinicalTrials.gov