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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Shan Sun, Ph.D
- 電話番号：+86-021-64377134-2033
- メール：sunshine7896@126.com
研究場所
-
-
-
Shanghai、中国、200031
- Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
-
コンタクト：
- Shan Sun, Ph.D
- 電話番号：+86-021-64377134-2033
- メール：sunshine7896@126.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
耳鳴障害インベントリー (THI)
時間枠：ベースライン、14日目、30日目
|
THI質問票は、機能的、感情的、破局的のサブスケールを含め、研究で広く使用されています。
25の質問で構成され、回答は「はい」（4点）、「ときどき」（2点）、「いいえ」（0点）の尺度で評価されます。
合計点は全ての質問のスコアを合計し、耳鳴りの重症度を無障害（0-16点）、軽度障害（18-36点）、中等度障害（38-56点）、重度障害（58-100点）に分類して算出されます。
|
ベースライン、14日目、30日目
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
患者健康質問票-2 (PHQ-2)
時間枠：ベースライン、14日目、30日目
|
PHQ-2は過去2週間の抑うつ症状を測定します。
2つの項目のそれぞれは0（「まったくない」）から3（「ほぼ毎日」）で評価されます。
合計スコアは0から6の範囲で、スコアが高いほど抑うつ症状が強いことを示します。
スコアが3以上の場合は臨床的に有意な抑うつを示唆します。
|
ベースライン、14日目、30日目
|
|
患者全体印象変化尺度 (PGIC)
時間枠：14日目、および30日目
|
PGICは、介入開始以降の参加者の全体的な改善認識を評価します。
これは、1（「非常に改善した」）から7（「非常に悪化した」）までの7段階のリッカート尺度で評価され、低いスコアはより大きな認識された改善を示します。
|
14日目、および30日目
|
|
Generalized Anxiety Disorder Scale (GAD-2)
時間枠：Baseline, Day 14, and Day 30]
|
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.
|
Baseline, Day 14, and Day 30]
|
|
Pittsburgh Sleep Quality Index (PSQI)
時間枠：Baseline, Day 14, and Day 30
|
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.
|
Baseline, Day 14, and Day 30
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ネットプロモータースコア (NPS)
時間枠：30日目
|
Net Promoter Score（NPS）は、参加者が30日目にFudan Tinnitus Doctorシステムを他者に推薦する可能性を評価するために使用されます。
参加者は0（全く可能性がない）から10（非常に可能性が高い）までの尺度で推薦可能性を評価します。
|
30日目
|
|
System Usability Scale (SUS)
時間枠：Day 30
|
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.
|
Day 30
|
|
User Engagement Metrics
時間枠：Continuous during 30-day intervention period
|
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
|
協力者と研究者
捜査官
- 主任研究者：Shan Sun、Eye and ENT Hospital of Fudan University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025072
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。