Trial · NCT07880561
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Change in Actigraphy-Derived Sleep Onset Latency (SOL-Actigraphy) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Actigraphy-Derived Wake After Sleep Onset (WASO-Actigraphy) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Actigraphy-Derived Time in Bed (TIB-Actigraphy) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Change in Actigraphy-Derived Sleep Efficiency (SE-Actigraphy) | Baseline and immediately after the 4-week intervention | 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. |
| Secondary | Intervention Satisfaction and Feasibility | Baseline and immediately after the 4-week intervention | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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