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Efficacy and Safety of LLM-Based CBT for Tinnitus

NCT07097909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-11-20

No results posted yet for this study

Summary

Given the limited evidence on digital cognitive behavioral therapy (CBT) for chronic subjective tinnitus, particularly interventions supported by large language models (LLMs), this two-arm, 30-day randomized controlled trial will aim to evaluate the efficacy, safety, and usability of an LLM-based conversational CBT intervention compared with a digital education control. Participants with chronic subjective tinnitus will be randomly assigned to either the intervention group, which will receive daily AI-supported CBT sessions through the Fudan Tinnitus Doctor (FTD) system, or the control group, which will receive static tinnitus education materials matched for duration and platform interface. The FTD system will be powered by a multi-agent large language model and will deliver personalized CBT-style dialogues, including psychoeducation, cognitive restructuring, relaxation, and mindfulness guidance. Outcomes will include tinnitus severity, sleep quality, mood symptoms, global improvement, and user adherence and experience.

Conditions

  • Tinnitus

Interventions

OTHER

Fudan Tinnitus Doctor (FTD) Conversational AI System

The FTD system will deliver personalized CBT-style dialogues including tinnitus psychoeducation, cognitive restructuring, relaxation training, sleep hygiene, and mindfulness guidance. The system will operate through a secure hospital web platform, accessible via personal devices, and will incorporate retrieval-augmented generation and safety moderation to ensure evidence-based and safe interaction.

OTHER

Digital Education Materials

Educational modules will include information on tinnitus mechanisms, common coping strategies, and general lifestyle recommendations. The materials will be accessed via the same secure platform as the intervention group to control for exposure time and digital interface effects.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Shan Sun, Ph.D · Eye and ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-02
Primary Completion
2025-09-19
Completion
2025-09-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07097909 on ClinicalTrials.gov