Clinical Research Directory
Browse clinical research sites, groups, and studies.
AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
Sponsor: Taipei Medical University
Summary
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, we 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. We 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-11-01
Completion Date
2027-08-31
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Digital BBTI-Based Sleep Management
Participants will receive a four-week digital sleep management intervention delivered through two independent platforms: a BBTI sleep diary website and a BBTI mobile application. Participants will record their sleep patterns daily through the website. The mobile application provides BBTI-related sleep education, behavioral sleep management information, and relaxation techniques to support insomnia management.
AI-Assisted Sleep Education and Personalized Guidance
Participants in the experimental group will additionally use an independent AI-powered website for four weeks. The website allows participants to ask questions about insomnia and sleep management, access sleep-related educational information, and receive AI-generated behavioral suggestions. The AI platform is intended to provide interactive and personalized guidance to support sleep management. It operates independently of the BBTI sleep diary website and mobile application.
Locations (1)
Taipei Medical University / Taipei Medical University Hospital
Taipei, Taiwan, Taiwan