A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fudan Tinnitus Doctor (FTD) System (Other)
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.
干预措施: Non-conversational Digital Education Program (Other)
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: 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).
次要结局
- 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)