Trial · NCT07880561
AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
NCT07880561, Not applicable, Not yet recruiting, Taipei Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation. Trials, record NCT07880561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
- NCT number
- NCT07880561
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Taipei Medical University
- Conditions
- Insomnia
- Interventions
- Digital BBTI-Based Sleep Management, AI-Assisted Sleep Education and Personalized Guidance
- First posted
- 2026-10-19
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia Severity Index (ISI) Score | 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. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) Score | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Epworth Sleepiness Scale (ESS) Score | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Depression, Anxiety and Stress Scales-21 (DASS-21) Scores | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Sleep Onset Latency (SOL) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Wake After Sleep Onset (WASO) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Total Sleep Time (TST) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Time in Bed (TIB) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Sleep Efficiency (SE) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Actigraphy-Derived Total Sleep Time (TST-Actigraphy) | Baseline and immediately after the 4-week intervention | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07880561
GET https://conductscience.org/api/trials/v1/NCT07880561/registered