An interventional study of Digital BBTI-Based Sleep Management and AI-Assisted Sleep Education and Personalized Guidance in Insomnia, sponsored by Taipei Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Baseline and immediately after the 4-week intervention
Pittsburgh Sleep Quality Index (PSQI) Score
Subjective sleep quality will be assessed using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). The questionnaire evaluates multiple dimensions of sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline and immediately after the 4-week intervention
Epworth Sleepiness Scale (ESS) Score
Daytime sleepiness will be assessed using the Chinese version of the Epworth Sleepiness Scale (ESS). The scale consists of 8 items assessing the likelihood of dozing in common daily situations. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.
Time frame: Baseline and immediately after the 4-week intervention
Depression, Anxiety and Stress Scales-21 (DASS-21) Scores
Psychological symptoms will be assessed using the 21-item Depression, Anxiety and Stress Scales (DASS-21). The instrument includes three subscales assessing depression, anxiety, and stress symptoms. Each subscale contains 7 items, with scores ranging from 0 to 42 after multiplying the summed score by 2. Higher scores indicate greater symptom severity.
Time frame: Baseline and immediately after the 4-week intervention
Change in Sleep Onset Latency (SOL)
Sleep onset latency will be derived from daily sleep diaries recorded through the BBTI sleep diary website and defined as the self-reported time from attempting to sleep to sleep onset, expressed in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Wake After Sleep Onset (WASO)
Wake after sleep onset will be derived from daily sleep diaries recorded through the BBTI sleep diary website and defined as the total self-reported time spent awake after initial sleep onset and before final awakening, expressed in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Total Sleep Time (TST)
Total sleep time will be derived from daily sleep diaries recorded through the BBTI sleep diary website and defined as the total self-reported amount of time spent asleep during the main sleep period, expressed in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Time in Bed (TIB)
Time in bed will be derived from daily sleep diaries recorded through the BBTI sleep diary website and defined as the interval between going to bed and getting out of bed, expressed in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Sleep Efficiency (SE)
Sleep efficiency will be derived from daily sleep diaries recorded through the BBTI sleep diary website and calculated as total sleep time divided by time in bed, multiplied by 100. Higher percentages indicate better sleep efficiency.
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Total Sleep Time (TST-Actigraphy)
Objective total sleep time will be assessed using a wrist-worn actigraphy device and expressed as the estimated total amount of time spent asleep during the main sleep period, measured in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Sleep Onset Latency (SOL-Actigraphy)
Objective sleep onset latency will be assessed using a wrist-worn actigraphy device and defined as the estimated time from attempting to sleep to sleep onset, expressed in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Wake After Sleep Onset (WASO-Actigraphy)
Objective wake after sleep onset will be assessed using a wrist-worn actigraphy device and defined as the estimated amount of time spent awake after initial sleep onset and before final awakening, expressed in minutes.
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy)
Time in bed will be derived from wrist-worn actigraphy data and defined as the duration of the designated sleep interval, expressed in minutes. Sleep diary information may be used to identify the rest interval.
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Sleep Efficiency (SE-Actigraphy)
Objective sleep efficiency will be assessed using a wrist-worn actigraphy device and calculated as the estimated total sleep time divided by time in bed, multiplied by 100. Higher percentages indicate better sleep efficiency.
Time frame: Baseline and immediately after the 4-week intervention
Intervention Satisfaction and Feasibility
Participants' satisfaction with and perceived feasibility of the digital insomnia management intervention will be assessed using a study-specific questionnaire. The questionnaire will evaluate ease of use, acceptability, perceived usefulness, and willingness to continue using the intervention. Participants in the AI-assisted group will also evaluate their experience with the AI-powered sleep education website.
Time frame: Baseline and immediately after the 4-week intervention
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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