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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shan Sun, Ph.D
- 전화번호: +86-021-64377134-2033
- 이메일: sunshine7896@126.com
연구 장소
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Shanghai, 중국, 200031
- Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
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연락하다:
- Shan Sun, Ph.D
- 전화번호: +86-021-64377134-2033
- 이메일: sunshine7896@126.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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이명 장애 인벤토리 (THI)
기간: 기준선, 14일차 및 30일차
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THI 설문지는 기능적, 정서적, 재앙적 하위 척도를 포함하여 연구에서 널리 사용됩니다.
25개 문항으로 구성되며, 응답은 "예"(4점), "가끔"(2점), "아니오"(0점) 척도로 평가됩니다.
총점은 모든 문항의 점수를 합산하여 이명의 심각도를 장애 없음(0-16점), 경미한 장애(18-36점), 중등도 장애(38-56점), 심각한 장애(58-100점)로 분류합니다.
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기준선, 14일차 및 30일차
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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환자 건강 설문-2 (PHQ-2)
기간: 기준선, 14일차 및 30일차
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PHQ-2는 지난 2주간의 우울 증상을 측정합니다.
두 항목 각각은 0("전혀 아님")에서 3("거의 매일")까지 점수화됩니다.
총점은 0에서 6까지이며, 점수가 높을수록 우울 증상이 더 심함을 나타냅니다.
3점 이상의 점수는 임상적으로 유의미한 우울증을 시사합니다.
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기준선, 14일차 및 30일차
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환자 전반적 변화 인상 (PGIC)
기간: 14일차 및 30일차
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PGIC는 중재 시작 이후 참가자의 전반적인 개선 인식을 평가합니다.
7점 리커트 척도(1점("매우 많이 개선됨")에서 7점("매우 많이 악화됨"))로 평가되며, 낮은 점수가 더 큰 인지된 개선을 나타냅니다.
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14일차 및 30일차
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Generalized Anxiety Disorder Scale (GAD-2)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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넷 프로모터 스코어 (NPS)
기간: 30일차
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Net Promoter Score(NPS)는 30일차에 참가자들이 푸단 이명 의사 시스템을 다른 사람에게 추천할 의향을 평가하는 데 사용됩니다.
참가자는 0(전혀 추천하지 않음)부터 10(매우 강력히 추천함)까지의 척도로 자신의 추천 의향을 평가합니다.
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30일차
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System Usability Scale (SUS)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Shan Sun, Eye and ENT Hospital of Fudan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025072
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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