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

NCT07880561 | Not Yet Recruiting

• 1 other identifier: N202507031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI) Score

  Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The ISI consists of 7 items assessing the severity and impact of insomnia symptoms. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.

  Baseline and immediately after the 4-week intervention

Secondary Outcomes (14)

• Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline and immediately after the 4-week intervention

• Epworth Sleepiness Scale (ESS) Score

  Baseline and immediately after the 4-week intervention

• Depression, Anxiety and Stress Scales-21 (DASS-21) Scores

  Baseline and immediately after the 4-week intervention

• Change in Sleep Onset Latency (SOL)

  Baseline and immediately after the 4-week intervention

• Change in Wake After Sleep Onset (WASO)

  Baseline and immediately after the 4-week intervention

Study Arms (2)

AI-Assisted Digital Insomnia Management

EXPERIMENTAL

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.

Behavioral: Digital BBTI-Based Sleep Management; Behavioral: AI-Assisted Sleep Education and Personalized Guidance

Standard Digital Insomnia Management

ACTIVE COMPARATOR

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.

Behavioral: Digital BBTI-Based Sleep Management

Interventions

Digital BBTI-Based Sleep Management BEHAVIORAL

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 Digital Insomnia Management; Standard Digital Insomnia Management

AI-Assisted Sleep Education and Personalized Guidance BEHAVIORAL

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.

AI-Assisted Digital Insomnia Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• shift worker.
• people with combined mental illnesses.
• alcohol dependence
• unable to use a phone due to cognititive impairment.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University / Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

HsinLing Yeh

CONTACT

+886-920-320-538; M432115001@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 19, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 19, 2026

Record last verified: 2026-10

Locations

TW (1)