AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation

MI-összefoglaló

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The trial is looking for adults diagnosed with insomnia who own a smartphone and can use a sleep app and online questionnaires on their own.

Életkor

18 years or older

Nem

All

A betegség stádiuma

Diagnosed insomnia with an Insomnia Severity Index (ISI) score of 8 or higher.

A részvétel fő kizáró okai

• Shift workers
• People who also have other mental illnesses
• Alcohol dependence
• Unable to use a phone because of problems with memory or thinking
• Unable to communicate in Chinese

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Insomnia is a prevalent global health problem, with approximately one in five Taiwanese adults chronically affected. Prolonged use of sedative-hypnotic medications carries risks of adverse effects, dependence, and unnecessary healthcare utilization. Although cognitive behavioral therapy for insomnia (CBT-I) is internationally recommended as first-line treatment, workforce shortages and suboptimal patient adherence limit its reach. This project will develop an artificial intelligence-driven mobile application for insomnia that implements the CBT-I components of stimulus control and sleep restriction. Using retrieval-augmented generation and large language models, **the investigators will build** a localized sleep knowledge base to deliver personalized, interactive sleep guidance. A pilot randomized controlled trial will assess the intervention's effectiveness in reducing insomnia severity and sedative-hypnotic use. **The investigators will subsequently pursue** a large-scale clinical trial and iterative model optimization, aiming to deliver the first clinically validated AI-enabled prescription digital therapeutic for insomnia and to advance smart healthcare in sleep care.

A vizsgálat 2 csoportja

• AI-Assisted Digital Insomnia ManagementA vizsgált kezelés

  Participants will use three independent digital platforms for four weeks: (1) a BBTI sleep diary website to record daily sleep patterns, (2) a BBTI mobile application providing sleep-related educational materials and relaxation techniques, and (3) an AI-powered website offering interactive sleep education and personalized sleep management suggestions. Participants can ask sleep-related questions and receive AI-generated responses.

  Kezelés: Digital BBTI-Based Sleep Management és AI-Assisted Sleep Education and Personalized Guidance

• Standard Digital Insomnia ManagementMár használt kezelés, összehasonlításként

  Participants will use two independent digital platforms for four weeks: (1) a BBTI sleep diary website to record daily sleep patterns and (2) a BBTI mobile application providing sleep-related educational materials and relaxation techniques. Participants will receive standard sleep management information without access to the AI-powered website.

  Kezelés: Digital BBTI-Based Sleep Management