Fudan Tinnitus Doctor for Tinnitus Management: A Randomized Controlled Trial

NCT07558837 | Not Yet Recruiting DMC

• 1 other identifier: 2025072
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Outcome Measures

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).

  Baseline, Day 14, and Day 30

Secondary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, Day 14, and Day 30

• Generalized Anxiety Disorder Scale (GAD-2)

  Baseline, Day 14, and Day 30]

• Patient Health Questionnaire-2 (PHQ-2)

  Baseline, Day 14, and Day 30

• Patient Global Impression of Change (PGIC)

  Day 14, and Day 30

Other Outcomes (3)

• System Usability Scale (SUS)

  Day 30

• Net Promoter Score (NPS)

  Day 30

• User Engagement Metrics

  Continuous during 30-day intervention period

Study Arms (2)

FTD Conversational AI Intervention

EXPERIMENTAL

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.

Other: Fudan Tinnitus Doctor (FTD) System

Digital Education Control

ACTIVE COMPARATOR

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.

Other: Non-conversational Digital Education Program

Interventions

Non-conversational Digital Education Program OTHER

This intervention includes structured educational articles and a predefined Q\&A module. It does not provide personalized or interactive conversational support.

Digital Education Control

Fudan Tinnitus Doctor (FTD) System OTHER

The FTD system is a conversational AI platform that provides real-time, personalized tinnitus management through multimodal interaction (text and voice). It integrates a large language model, retrieval-augmented generation, and multi-agent collaboration to deliver CBT-based interventions, including psychoeducation, cognitive restructuring, relaxation techniques, and sleep hygiene guidance.

FTD Conversational AI Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Perceptibility: Tinnitus is present and recognizable by the participant under ordinary daily conditions (not only in quiet environments).
• 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.

You may not qualify if:

• 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.
• Testing limitations: Inability to adequately complete tinnitus testing procedures or comply with study assessments.
• Prior therapy exposure: Previous history of sound therapy specifically for tinnitus management.
• Concurrent treatments: Ongoing psychotherapy for conditions such as anxiety or depression, or any other psychological treatment that may interfere with the study endpoints.
• 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.
• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department

Shanghai, 200031, China

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Shan Sun

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan Sun, Ph.D

CONTACT

+86-021-64377134-2033; sunshine7896@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)