Fudan Tinnitus Doctor for Tinnitus Management
A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomized Controlled 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a prospective, two-arm, parallel-group, open-label randomized controlled trial designed to evaluate the efficacy, usability, and safety of a multi-agent large language model (LLM)-based conversational artificial intelligence system (Fudan Tinnitus Doctor, FTD) for the management of chronic subjective tinnitus.
A total of 256 participants will be randomized in a 1:1 ratio to either the FTD intervention or a non-conversational digital education control. The intervention period is 30 days. The FTD system delivers personalized, real-time tinnitus management using a multi-agent architecture integrating cognitive behavioral therapy (CBT)-based strategies, including psychoeducation, cognitive restructuring, relaxation training, and sleep hygiene guidance. The control group receives a static digital program consisting of educational materials and a fixed-response question-and-answer module.
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 outcomes will be analyzed using mixed-effects models under the intention-to-treat principle.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Shan Sun, Ph.D
- Número de telefone: +86-021-64377134-2033
- E-mail: sunshine7896@126.com
Locais de estudo
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Shanghai, China, 200031
- Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
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Contato:
- Shan Sun, Ph.D
- Número de telefone: +86-021-64377134-2033
- E-mail: sunshine7896@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: FTD Conversational AI Intervention
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.
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The FTD system is a multi-agent conversational artificial intelligence platform that delivers personalized tinnitus management through a secure web-based interface.
It supports multimodal interaction (text and voice) and integrates a large language model, retrieval-augmented generation, and multi-agent collaboration to provide cognitive behavioral therapy-based interventions, including psychoeducation, cognitive restructuring, relaxation techniques, and sleep hygiene guidance.
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Comparador Ativo: Digital Education Control
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.
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Participants in this arm will receive access to a non-conversational digital tinnitus self-management program delivered through the same secure web-based interface as the intervention group.
The program provides static educational materials and a fixed-response question-and-answer module related to tinnitus, sleep, and mental health.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Inventário de Incapacidade do Zumbido (THI)
Prazo: Linha de base, Dia 14 e Dia 30
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O questionário THI, amplamente utilizado na investigação, incluindo subescalas funcionais, emocionais e catastróficas.
Consiste em 25 perguntas, e as respostas são classificadas numa escala de "sim" (4 pontos), "às vezes" (2 pontos) e "não" (0 pontos).
A pontuação total é calculada somando as pontuações de todas as perguntas e classificando a gravidade do tinnitus como sem incapacidade (0-16), incapacidade ligeira (18-36), incapacidade moderada (38-56) e incapacidade grave (58-100).
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Linha de base, Dia 14 e Dia 30
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Questionário de Saúde do Paciente-2 (PHQ-2)
Prazo: Linha de Base, Dia 14 e Dia 30
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O PHQ-2 irá medir os sintomas depressivos nas últimas duas semanas.
Cada um dos dois itens é classificado de 0 ("nada") a 3 ("quase todos os dias").
A pontuação total varia de 0 a 6, com pontuações mais altas a indicar sintomas depressivos mais graves.
Uma pontuação ≥3 sugere depressão clinicamente significativa.
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Linha de Base, Dia 14 e Dia 30
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Impressão Global do Doente sobre a Mudança (PGIC)
Prazo: Dia 14 e Dia 30
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O PGIC irá avaliar a perceção global do participante relativamente à melhoria desde o início da intervenção.
É classificado numa escala de Likert de 7 pontos, de 1 ("melhorou muito") a 7 ("piorou muito"), com pontuações mais baixas a representar uma maior perceção de melhoria.
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Dia 14 e Dia 30
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Generalized Anxiety Disorder Scale (GAD-2)
Prazo: Baseline, Day 14, and Day 30]
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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.
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Baseline, Day 14, and Day 30]
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Pittsburgh Sleep Quality Index (PSQI)
Prazo: Baseline, Day 14, and Day 30
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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).
The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
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Baseline, Day 14, and Day 30
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Pontuação de Promotor Líquido (NPS)
Prazo: Dia 30
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O Net Promoter Score (NPS) será utilizado para avaliar a probabilidade de os participantes recomendarem o sistema Fudan Tinnitus Doctor a outros no Dia 30.
Os participantes classificarão a sua probabilidade numa escala de 0 (nada provável) a 10 (extremamente provável).
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Dia 30
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System Usability Scale (SUS)
Prazo: Day 30
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The System Usability Scale (SUS) will be used to evaluate participants' perceived usability and satisfaction with the Fudan Tinnitus Doctor (FTD) conversational AI system at Day 30.
The SUS is a 10-item questionnaire rated on a 5- point scale.
The total score will be calculated as (sum of adjusted item scores × 2.5), ranging from 0 to 100, with higher scores indicating greater usability.
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Day 30
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User Engagement Metrics
Prazo: Continuous during 30-day intervention period
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User engagement will be assessed using three predefined system-recorded metrics: (1)Login Frequency: Number of logins. (2)Active Session Duration: Total time (minutes) spent actively interacting with the system, excluding inactive periods and time spent completing study assessments. (3)Conversation Turns: Number of complete interaction cycles, defined as one user input followed by one system response. Higher values indicate greater engagement. |
Continuous during 30-day intervention period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shan Sun, Eye and ENT Hospital of Fudan University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025072
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