TinnitusNCT07097909
Efficacy and Safety of LLM-Based CBT for Tinnitus
A study testing Fudan Tinnitus Doctor (FTD) Conversational AI System and Digital Education Materials in people with Tinnitus, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Fudan Tinnitus Doctor (FTD) Conversational AI System and Digital Education Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2025to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
Shanghai, Shanghai Municipality, 200031
About this study
Official title: A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomised Controlled Trial
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.
Read the detailed description
Chronic subjective tinnitus is a common and often distressing auditory condition that frequently co-occurs with insomnia, anxiety, and depression. Cognitive behavioral therapy (CBT) remains the most evidence-based treatment to reduce tinnitus-related distress, but traditional face-to-face CBT is limited by accessibility, cost, and availability of trained professionals. Digital CBT interventions have demonstrated potential benefits, yet their efficacy varies, and engagement and personalization remain major challenges.
Recent advances in large language models (LLMs) have enabled the development of interactive conversational systems capable of delivering psychologically informed support. The Fudan Tinnitus Doctor (FTD) is a multi-agent conversational AI platform specifically designed to provide CBT-based tinnitus management. It integrates psychoeducation, cognitive restructuring, relaxation, and mindfulness guidance within natural language conversations. The system will be powered by a multi-agent large language model with retrieval-augmented generation (RAG) and safety moderation to ensure content validity, consistency, and user safety.
This single-centre, parallel-group, open-label randomized controlled trial will evaluate the efficacy, safety, and usability of the FTD system compared with a digital education control. Participants with chronic subjective tinnitus meeting the inclusion criteria will be randomly assigned (1:1) to either the FTD intervention group or the control group. The intervention group will receive 30 days of AI-supported CBT sessions through the secure hospital web platform, while the control group will receive static tinnitus education materials matched for platform and duration but without interactive AI components.
The primary outcome will be the change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI) from baseline to Day 30. Secondary outcomes will include sleep quality (Pittsburgh Sleep Quality Index, PSQI), anxiety (GAD-2), depression (PHQ-2), and overall perceived improvement (Patient Global Impression of Change, PGIC). Exploratory outcomes will assess usability (System Usability Scale, SUS), satisfaction (Net Promoter Score, NPS), and engagement metrics.
All assessments will use validated Chinese versions of the respective questionnaires. Safety monitoring will be conducted throughout the study period. Adverse events and any AI-related performance errors will be automatically logged and reviewed by the research team.
This study will provide preliminary evidence on the efficacy and safety of an LLM-based conversational CBT system for tinnitus management, offering a scalable and patient-centered approach that could enhance accessibility and adherence in digital mental health care.
- Conditions
- Tinnitus
- Being tested
- Fudan Tinnitus Doctor (FTD) Conversational AI System, Digital Education Materials
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fudan Tinnitus Doctor (FTD) Conversational AI SystemOther
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.
Digital Education MaterialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LLM-based Conversational CBT (FTD) | Experimental | Participants in this group will receive a 30-day self-directed intervention delivered through the Fudan Tinnitus Doctor (FTD) system, a multi-agent large language model-based conversational AI platform designed to provide tinnitus-focused cognitive behavioural therapy. Receives: Other: Fudan Tinnitus Doctor (FTD) Conversational AI System |
| Digital Education Control Group | Active comparator | Participants in this group will receive static, evidence-based tinnitus education materials presented through the same digital platform, matched in format and duration to the intervention group but without interactive AI components. Receives: Other: Digital Education Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Day 14, and Day 30
Secondary outcomes (4)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI will be used to evaluate subjective sleep quality over the past month. It comprises 19 items yielding seven component scores (subjective sleep quality, latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction). Higher total scores indicate poorer sleep quality.
Measured: Baseline, Day 14, and Day 30
Generalized Anxiety Disorder Scale (GAD-2)
The GAD-2 will assess anxiety symptoms over the past two weeks. Each of the two items is rated from 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 6, with higher scores indicating greater anxiety. A score ≥3 suggests clinically significant anxiety.
Measured: Baseline, Day 14, and Day 30
Patient Health Questionnaire-2 (PHQ-2)
The PHQ-2 will measure depressive symptoms over the past two weeks. Each of the two items is rated from 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 6, with higher scores indicating greater depressive symptoms. A score ≥3 suggests clinically significant depression.
Measured: Baseline, Day 14, and Day 30
Patient Global Impression of Change (PGIC)
The PGIC will assess the participant's overall perception of improvement since starting the intervention. It is rated on a 7-point Likert scale from 1 ("very much improved") to 7 ("very much worse"), with lower scores representing greater perceived improvement.
Measured: Day 14, and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start2 Aug 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan Sun, Ph.D, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097909
- Sponsor's protocol ID
- LLM-TCBT
- Status last verified
- Oct 2025
- First submitted
- 30 Jul 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data (IPD) collected for this trial, including outcome measures and baseline characteristics, will be made available upon reasonable request to qualified researchers. Data sharing will require prior approval from the Institutional Review Board of the Eye \& ENT Hospital of Fudan University. The DeepSeek-R1 671B model used to support the intervention is open-source and publicly accessible at https://github.com/deepseek-ai/DeepSeek-R1.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07097909
- Acronym / sponsor ID
- LLM-TCBT
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic subjective tinnitus is a common and often distressing auditory condition that frequently co-occurs with insomnia, anxiety, and depression. Cognitive behavioral therapy (CBT) remains the most evidence-based treatment to reduce tinnitus-related distress, but traditional face-to-face CBT is limited by accessibility, cost, and availability of trained professionals. Digital CBT interventions have demonstrated potential benefits, yet their efficacy varies, and engagement and personalization remain major challenges.
Recent advances in large language models (LLMs) have enabled the development of interactive conversational systems capable of delivering psychologically informed support. The Fudan Tinnitus Doctor (FTD) is a multi-agent conversational AI platform specifically designed to provide CBT-based tinnitus management. It integrates psychoeducation, cognitive restructuring, relaxation, and mindfulness guidance within natural language conversations. The system will be powered by a multi-agent large language model with retrieval-augmented generation (RAG) and safety moderation to ensure content validity, consistency, and user safety.
This single-centre, parallel-group, open-label randomized controlled trial will evaluate the efficacy, safety, and usability of the FTD system compared with a digital education control. Participants with chronic subjective tinnitus meeting the inclusion criteria will be randomly assigned (1:1) to either the FTD intervention group or the control group. The intervention group will receive 30 days of AI-supported CBT sessions through the secure hospital web platform, while the control group will receive static tinnitus education materials matched for platform and duration but without interactive AI components.
The primary outcome will be the change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI) from baseline to Day 30. Secondary outcomes will include sleep quality (Pittsburgh Sleep Quality Index, PSQI), anxiety (GAD-2), depression (PHQ-2), and overall perceived improvement (Patient Global Impression of Change, PGIC). Exploratory outcomes will assess usability (System Usability Scale, SUS), satisfaction (Net Promoter Score, NPS), and engagement metrics.
All assessments will use validated Chinese versions of the respective questionnaires. Safety monitoring will be conducted throughout the study period. Adverse events and any AI-related performance errors will be automatically logged and reviewed by the research team.
This study will provide preliminary evidence on the efficacy and safety of an LLM-based conversational CBT system for tinnitus management, offering a scalable and patient-centered approach that could enhance accessibility and adherence in digital mental health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-based Conversational CBT (FTD) | Experimental | Other: Fudan Tinnitus Doctor (FTD) Conversational AI SystemParticipants in this group will receive a 30-day self-directed intervention delivered through the Fudan Tinnitus Doctor (FTD) system, a multi-agent large language model-based conversational AI platform designed to provide tinnitus-focused cognitive behavioural therapy. |
| Digital Education Control Group | Active comparator | Other: Digital Education MaterialsParticipants in this group will receive static, evidence-based tinnitus education materials presented through the same digital platform, matched in format and duration to the intervention group but without interactive AI components. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fudan Tinnitus Doctor (FTD) Conversational AI SystemThe 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 | LLM-based Conversational CBT (FTD) |
| Digital Education MaterialsEducational 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. | Other | Digital Education Control Group |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: Baseline, Day 14, and Day 30
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).
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Day 14, and Day 30
Generalized Anxiety Disorder Scale (GAD-2)
Time frame: Baseline, Day 14, and Day 30
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Baseline, Day 14, and Day 30
Patient Global Impression of Change (PGIC)
Time frame: Day 14, and Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. Deidentified individual participant data (IPD) collected for this trial, including outcome measures and baseline characteristics, will be made available upon reasonable request to qualified researchers. Data sharing will require prior approval from the Institutional Review Board of the Eye \& ENT Hospital of Fudan University. The DeepSeek-R1 671B model used to support the intervention is open-source and publicly accessible at https://github.com/deepseek-ai/DeepSeek-R1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Sun, Ph.D principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fudan Tinnitus Doctor (FTD) Conversational AI System and Digital Education Materials in people with Tinnitus, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: Baseline, Day 14, and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.