AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
Key facts
- Where
- Taipei, TaiwanSee the site
Where in Taiwan
- Taipei Medical University - Taipei Medical University HospitalTaipei, TaiwanContact: HsinLing YehNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Taipei Medical University
- Trial code
- NCT07880561
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Aged 18 years or older; An Insomina Severity Index(ISI) score of 8og higher; Diagnosed with insomnia; Ownership of a smartphone; Ability to operate the application and complete online questionnaires independently; Chinese communication.
Exclusion: people with combined mental illnesses; unable to use a phone due to cognititive impairment; shift worker; alcohol dependence.