InsomniaBBTI appNCT07880561
AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
A study testing Digital BBTI-Based Sleep Management and AI-Assisted Sleep Education and Personalized Guidance in people with Insomnia, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Digital BBTI-Based Sleep Management and AI-Assisted Sleep Education and Personalized Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- shift worker.
- people with combined mental illnesses.
- alcohol dependence
- unable to use a phone due to cognititive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University / Taipei Medical University Hospital
Taipei, Taiwan
HsinLing Yeh, +886-920-320-538, M432115001@tmu.edu.tw
About this study
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.
- Conditions
- Insomnia
- Being tested
- Digital BBTI-Based Sleep Management, AI-Assisted Sleep Education and Personalized Guidance
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital BBTI-Based Sleep ManagementBehavioural
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 GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Digital BBTI-Based Sleep Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI) Score
Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The scale 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 (minimum) to 28 (maximum). Higher scores indicate greater insomnia severity and therefore a worse outcome.
Measured: Baseline and immediately after the 4-week intervention
Secondary outcomes (14)
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 (minimum) to 21 (maximum). Higher scores indicate poorer sleep quality and therefore a worse outcome.
Measured: 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. Each item is rated from 0 to 3, yielding a total score ranging from 0 (minimum) to 24 (maximum). Higher scores indicate greater daytime sleepiness and therefore a worse outcome.
Measured: Baseline and immediately after the 4-week intervention
Depression, Anxiety and Stress Scales-21 (DASS-21) Scores
Psychological symptoms will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21). The instrument consists of 21 items divided into three subscales assessing depression, anxiety, and stress. Each subscale includes 7 items rated from 0 to 3. The sum of each subscale is multiplied by 2, yielding a score ranging from 0 (minimum) to 42 (maximum) for each subscale. Higher scores indicate greater psychological symptom severity and therefore a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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. Each item will be rated on a 5-point Likert scale ranging from 1 (minimum) to 5 (maximum), with higher scores indicating greater satisfaction and perceived feasibility and therefore a better outcome.
Measured: Baseline and immediately after the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880561
- Sponsor's protocol ID
- N202507031
- Acronym
- BBTI app
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
- ClinicalTrials.gov ID
- NCT07880561
- Acronym / sponsor ID
- BBTI app / N202507031
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Digital Insomnia Management | Experimental | Behavioral: Digital BBTI-Based Sleep Management, Behavioral: AI-Assisted Sleep Education and Personalized GuidanceParticipants 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. |
| Standard Digital Insomnia Management | Active comparator | Behavioral: Digital BBTI-Based Sleep ManagementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- shift worker.
- people with combined mental illnesses.
- alcohol dependence
- unable to use a phone due to cognititive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital BBTI-Based Sleep ManagementParticipants 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. | Behavioural | AI-Assisted Digital Insomnia Management, Standard Digital Insomnia Management |
| AI-Assisted Sleep Education and Personalized GuidanceParticipants 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. | Behavioural | AI-Assisted Digital Insomnia Management |
Primary outcome
Insomnia Severity Index (ISI) Score
Time frame: Baseline and immediately after the 4-week intervention
Insomnia severity will be assessed using the Chinese version of the Insomnia Severity Index (C-ISI). The scale 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 (minimum) to 28 (maximum). Higher scores indicate greater insomnia severity and therefore a worse outcome.
14 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and immediately after the 4-week intervention
Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and immediately after the 4-week intervention
Depression, Anxiety and Stress Scales-21 (DASS-21) Scores
Time frame: Baseline and immediately after the 4-week intervention
Change in Sleep Onset Latency (SOL)
Time frame: Baseline and immediately after the 4-week intervention
Change in Wake After Sleep Onset (WASO)
Time frame: Baseline and immediately after the 4-week intervention
Change in Total Sleep Time (TST)
Time frame: Baseline and immediately after the 4-week intervention
Change in Time in Bed (TIB)
Time frame: Baseline and immediately after the 4-week intervention
Change in Sleep Efficiency (SE)
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Total Sleep Time (TST-Actigraphy)
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Sleep Onset Latency (SOL-Actigraphy)
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Wake After Sleep Onset (WASO-Actigraphy)
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy)
Time frame: Baseline and immediately after the 4-week intervention
Change in Actigraphy-Derived Sleep Efficiency (SE-Actigraphy)
Time frame: Baseline and immediately after the 4-week intervention
Intervention Satisfaction and Feasibility
Time frame: Baseline and immediately after the 4-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital BBTI-Based Sleep Management and AI-Assisted Sleep Education and Personalized Guidance in people with Insomnia, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HsinLing Yeh (+886-920-320-538, M432115001@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) Score (time frame: Baseline and immediately after the 4-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.