Efficacy and Safety of LLM-Based CBT for Tinnitus

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of therapy to help people with tinnitus, which is a condition where you hear ringing or buzzing in your ears that isn’t caused by an external sound. The therapy uses a smartphone app powered by advanced computer technology called a large language model (LLM) to deliver daily sessions of cognitive behavioral therapy (CBT). CBT is a type of talk therapy that helps change negative thoughts and teaches relaxation techniques, which may reduce the distress caused by tinnitus. The study will last about 8 weeks and will look at how well this app helps with tinnitus severity, sleep quality, mood, and how easy it is for people to stick with the program.

People who might be eligible to join are adults aged 18 to 70 who have had tinnitus for at least 3 months and have a moderate to severe level of symptoms, as measured by a standard questionnaire. Participants need to be comfortable using a smartphone and willing to agree to participate in the study. The trial does not include people with certain types of tinnitus caused by blood flow issues, serious ear diseases, severe mental health problems, or those currently in other similar treatments. If you join, you will use the app every day to complete therapy exercises designed to help you manage your tinnitus better. This study is not yet recruiting participants but aims to learn if this digital therapy is both safe and helpful.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chronic subjective tinnitus lasting for ≥3 months;
• • Tinnitus Handicap Inventory (THI) score ≥18;
• • Age between 18 and 70 years, regardless of gender;
• • Ability to use a smartphone;
• • Willingness to provide written informed consent.
• Exclusion Criteria:
• • Pulsatile tinnitus or objective tinnitus;
• • Organic ear diseases;
• • Severe psychiatric disorders (e.g., schizophrenia);
• • Recent participation in other CBT interventions or drug trials for tinnitus;
• • Determined by the investigators to be unsuitable for participation in this study.