InsominaNCT07600840
Integrating Smart Wearable Device Into Digital Insomnia Treatment Application: Exploration of Combining Emotional and Lifestyle Records
A study testing Personalized Experience Sampling Method and Non-personalized Experience Sampling Method in people with Insomina and Mood Change, run by National Taipei University of Technology at 1 site in Taiwan.
Trial summary
Emotions, behavior, and cognition are the main factors contributing to insomnia. Insomnia not only affects sleep quality but also harms health, quality of life, and daytime functioning. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomina, Mood Change
- What is being tested?
- Personalized Experience Sampling Method and Non-personalized Experience Sampling Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Apr 2026to Jun 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 64 years
- Complaints of insomnia symptoms
- Insomnia Severity Index (ISI) total score ≥ 8
- Able to express emotions and physical/mental condition normally
- Able to independently complete questionnaires
- Able to cooperate with wearing smart watches and EEG devices Subjects Without Insomnia
Show all 33Show fewer
- Aged 18 to 64 years
- Insomnia Severity Index (ISI) total score < 8
- Able to express emotions and physical/mental condition normally
- Able to independently complete questionnaires
- Able to cooperate with wearing smart watches and EEG devices
- Experimental Phase 2 Insomnia Subjects
- Aged 18 to 64 years
- Complaints of insomnia symptoms
- Insomnia Severity Index (ISI) total score ≥ 8
- Able to express emotions and physical/mental condition normally
- Able to independently complete questionnaires
- Able to cooperate with wearing smart watches and EEG devices
- Owns an iOS device capable of downloading the experimental application Subjects Without Insomnia
- Aged 18 to 64 years
- Insomnia Severity Index (ISI) total score < 8
- Able to express emotions and physical/mental condition normally
- Able to independently complete questionnaires
- Able to cooperate with wearing smart watches and EEG devices
- Owns an iOS device capable of downloading the experimental application
- Phase III
- Aged 18 to 64 years
- Complaints of insomnia symptoms (e.g., total wakefulness at night for at least 30 minutes, occurring more than 3 days per week for at least 3 months)
- Insomnia Severity Index (ISI) total score ≥ 8
- Able to express emotions and physical/mental condition normally
- Able to independently complete questionnaires
- Able to cooperate with wearing a smart watch
- Able to use the system for recording over a four-week period
Who cannot join
- Previously diagnosed with epilepsy
- Complaints of other sleep disorders
- Current diagnosis of a psychiatric disorder requiring treatment
- History of substance abuse or alcohol dependence
- Pregnant or breastfeeding women
- Women experiencing severe menopausal symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integrating Smart Wearable Devices Into Digital Insomnia Treatment Applications: An Exploration of Combining Emotional and Lifestyle Records
Emotions, behavior, and cognition are the main factors contributing to insomnia. Insomnia not only affects sleep quality but also harms health, quality of life, and daytime functioning. Brief Behavioral Treatment for Insomnia (BBTI) is considered a short-term effective treatment for insomnia and has been implemented on online platforms.
However, the causes of insomnia are complex, and when designing related digital products, it is essential to consider the psychological and lifestyle states of individuals with insomnia, employing a user-centered approach and interactive design.
Read more
Previous research has integrated emotion tracking and an abdominal breathing game into the existing BBTI APP. This study will further incorporate the tracking of emotions and lifestyle factors (specifically diet and exercise) into a digital insomnia application, while also connecting with smartwatches and using the Experience Sampling Method (ESM) to collect data. It aims to explore the preferences of individuals with insomnia for digital tracking and examine the impact of their recorded information related to insomnia on their sleep and self-management.
The ultimate goal of this study is to enhance the existing insomnia app's features, offering innovative and convenient self-monitoring methods to help therapists better understand the condition of individuals with insomnia, while improving self-awareness and self-management. The anticipated results are expected to provide design recommendations for future digital applications related to insomnia, thereby improving the digital healthcare experience and medical efficacy.
- Conditions
- Insomina, Mood Change
- Being tested
- Personalized Experience Sampling Method, Non-personalized Experience Sampling Method
- Keywords
- insomnia, bbti, Mood, Lifestyle, Digital recording,, Experience Sampling Method, Wearable Devices
- 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.
Personalized Experience Sampling MethodDevice
Reminder times will be personalized based on participants' lifestyle patterns. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study.
Non-personalized Experience Sampling MethodDevice
Reminder times will be preset by the researchers. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Experience Sampling Method | Experimental | Reminder times will be personalized based on participants' lifestyle patterns. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study. Receives: Device: Personalized Experience Sampling Method |
| Non-personalized Experience Sampling Method | Other | Reminder times will be preset by the researchers. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study. Receives: Device: Non-personalized Experience Sampling Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insomnia Severity
Insomnia severity will be measured using the Insomnia Severity Index (ISI). The ISI consists of seven items, with each item rated from 0 to 4, resulting in a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity. Changes in ISI scores will be used to evaluate whether the BBTI app intervention improves participants' insomnia symptoms.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Sleep Quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep-related problems. Higher scores indicate poorer sleep quality. PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Emotional State: BBTI App self-record
Participants' emotional state will be measured through app-based self-reports and/or standardized emotional state questionnaires. Emotional records may include daily mood, stress, anxiety, or other sleep-related psychological states. Changes in emotional state will be used to examine whether lifestyle and sleep self-monitoring through the BBTI app is associated with emotional awareness and psychological well-being.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Changes in Emotional State: Profile of Mood States
The Profile of Mood States (POMS) is a self-administered questionnaire that measures mood through ratings of 65 emotion terms on a five-point scale.
A Total Mood Disturbance (TMD) can be calculated by adding Tension, Depression, Anger, Fatigue and Confusion scores and then subtracting the Vigour score. TMD = (Tension + Depression + Anger + Fatigue + Confusion) - Vigour.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Response Rate for Sleep-Related Lifestyle Self-Monitoring
The response rate for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the percentage of lifestyle self-monitoring reminders followed by at least one completed relevant entry.
Unit of Measure：Percentage of reminders followed by a completed entry (%)
Measured: From Day 1 to Day 28 of the intervention period
Response Latency for Sleep-Related Lifestyle Self-Monitoring
Response latency for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the average time between the delivery of a lifestyle self-monitoring reminder and the completion of a relevant entry.
Unit of Measure：Minutes
Measured: From Day 1 to Day 28 of the intervention period
Overall Self-Monitoring Completion Rate Assessed by the BBTI App
Overall self-monitoring completion rate will be assessed using app usage records from the BBTI app. This measure will be calculated as the percentage of scheduled daily self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries.
Unit of Measure：Percentage of scheduled self-monitoring tasks completed (%)
Measured: From Day 1 to Day 28 of the intervention period
Difference in Overall Self-Monitoring Completion Rate Between Personalized and Non-Personalized ESM Reminder Groups
The difference in overall self-monitoring completion rate between the personalized ESM reminder group and the non-personalized ESM reminder group will be assessed using app usage records from the BBTI app. Overall self-monitoring completion rate will be calculated as the percentage of scheduled self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries. The personalized ESM reminder group will receive reminders based on individual lifestyle patterns, while the non-personalized ESM reminder group will receive reminders at fixed times.
Unit of Measure：Difference in percentage of scheduled self-monitoring tasks completed between groups (%)
Measured: From Day 1 to Day 28 of the intervention period
Changes in Sleep-Related Lifestyle Behaviors: BBTI App Self-Record
Participants' sleep-related lifestyle behaviors will be measured through app-based self-records in the BBTI app. Lifestyle records will include meal timing and perceived fullness, caffeinated beverage intake time and amount, and exercise timing and exercise amount. Changes in sleep-related lifestyle behaviors will be used to examine participants' self-monitoring patterns and changes in lifestyle behaviors during the intervention.
Measured: From Day 1 to Day 28 of the intervention period
Changes in Perceived Capability, Opportunity, and Motivation for Lifestyle Self-Monitoring
Participants' perceived capability, opportunity, and motivation for insomnia-related lifestyle self-monitoring will be assessed using a COM-B-based self-report questionnaire. The questionnaire will evaluate participants' perceived capability to record lifestyle behaviors, perceived opportunity to perform self-monitoring, and motivation to continue tracking sleep-related lifestyle factors. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores.
Unit of Measure：Change in mean questionnaire score
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Change in Insomnia-Related Lifestyle Knowledge, Attitudes, and Behaviors
Insomnia-related lifestyle knowledge, attitudes, and behaviors will be assessed using a self-report questionnaire. The questionnaire will evaluate participants' knowledge of sleep-related lifestyle factors, attitudes toward lifestyle self-monitoring and behavior change, and self-reported lifestyle behaviors related to insomnia management. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores.
Unit of Measure：Change in mean questionnaire score
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Secondary outcomes (14)
Brief Symptom Rating Scale-5 (BSRS-5)
The BSRS-5 asks patients to reflect on the past week (including the assessment day) and rate their level of distress or discomfort. A total score of ≤3 indicates low suicide risk. It uses a 5-point Likert scale and contains 6 items.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
WHO-5 Well-Being Index
The WHO-5 measures subjective mental well-being and quality of life over the past two weeks using 5 items on a 6-point Likert scale.
Scoring: Raw scores range from 0-25, with higher scores indicating better well-being. Multiply the raw score by 4 to obtain a percentage score (0-100).
Interpretation: Further assessment for major depression (ICD-10) is recommended if the raw score is below 13 or if any item is rated 0 or 1.
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Rating Scale of Mental Effort in App Use Experience
The RSME measures the level of mental effort experienced while performing a task. Scores range from 0 to 150, with higher scores indicating greater mental effort.
Measured: at baseline, Week 2, and Week 4, participants completed the in-app assessment before the task and after completing the intervention.
Average Sleep Score Collected by Smartwatch
Average sleep score will be assessed using sleep data collected by a smartwatch. This measure will be calculated as the average nightly sleep score during the intervention period.
Unit of Measure：Sleep score
Measured: From Day 1 to Day 28 of the intervention period
Average Daily Step Count Collected by Smartwatch
Average daily step count will be assessed using physical activity data collected by a smartwatch. This measure will be calculated as the average number of steps per day during the intervention period.
Unit of Measure：Steps per day
Measured: From Day 1 to Day 28 of the intervention period
Average Active Energy Expenditure Collected by Smartwatch
Average active energy expenditure will be assessed using physical activity data collected by a smartwatch. This measure will be calculated as the average active energy expenditure per day during the intervention period.
Unit of Measure：Kilocalories per day
Measured: From Day 1 to Day 28 of the intervention period
Average Heart Rate Collected by Smartwatch
Average heart rate will be assessed using physiological data collected by a smartwatch. This measure will be calculated as the average heart rate during the intervention period.
Unit of Measure：Beats per minute
Measured: From Day 1 to Day 28 of the intervention period
Average Heart Rate Variability Collected by Smartwatch
Average heart rate variability will be assessed using physiological data collected by a smartwatch. This measure will be calculated as the average heart rate variability during the intervention period.
Unit of Measure：Milliseconds
Measured: From Day 1 to Day 28 of the intervention period
System Usability Assessed by the System Usability Scale
System usability will be assessed using the System Usability Scale after the 4-week intervention. The scale will evaluate participants' subjective perceptions of system usability, learnability, and overall satisfaction with the BBTI app and self-monitoring system.
Unit of Measure：System Usability Scale score
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
User Experience of the BBTI App: User Experience Questionnaire
Participants' user experience of the BBTI app will be assessed using the User Experience Questionnaire (UEQ). The questionnaire will evaluate participants' perceptions of the app across user experience dimensions, such as attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty. The UEQ score will be used to assess participants' subjective experience of using the BBTI app and smartwatch-supported lifestyle self-monitoring system.
Unit of Measure：UEQ mean scale score
Measured: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Cognitive Load During Usability Testing Assessed by NASA-TLX
Cognitive load during usability testing will be assessed using the NASA Task Load Index (NASA-TLX). Participants will complete the NASA-TLX after operating the prototype. The scale will assess perceived workload, including mental demand, physical demand, temporal demand, performance, effort, and frustration.
Unit of Measure：NASA-TLX score
Measured: During usability testing, Day 1
Attention Level During Prototype Operation Assessed by EEG
Attention level during prototype operation will be assessed using an electroencephalography device during usability testing. The measure will be calculated based on the attention index or attention-related EEG indicator recorded while participants operate the prototype.
Measured: During usability testing, Day 1
Heart Rate Variability During Usability Testing
Heart rate variability during usability testing will be assessed using physiological data collected while participants operate the prototype. This measure will be calculated as the average heart rate variability during prototype operation.
Unit of Measure：Milliseconds
Measured: During usability testing, Day 1
Insight Formation Ability During Lifestyle Data Visualization Review
Insight formation ability will be assessed during usability testing based on participants' responses while reviewing lifestyle data visualizations. The analysis will refer to North's insight-based evaluation approach to evaluate the degree to which participants generate meaningful insights from lifestyle data charts.
Unit of Measure：Insight formation score
Measured: During usability testing, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start16 Apr 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsominaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ko-Chiu, Wu, National Taipei University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600840
- Sponsor's protocol ID
- N202502043
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Smart Wearable Devices Into Digital Insomnia Treatment Applications: An Exploration of Combining Emotional and Lifestyle Records
- ClinicalTrials.gov ID
- NCT07600840
- Acronym / sponsor ID
- N202502043
- Conditions
- Insomina, Mood Change
- Keywords
- insomnia, bbti, Mood, Lifestyle, Digital recording,, Experience Sampling Method, Wearable Devices
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taipei University of TechnologyUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 May 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.
Emotions, behavior, and cognition are the main factors contributing to insomnia. Insomnia not only affects sleep quality but also harms health, quality of life, and daytime functioning. Brief Behavioral Treatment for Insomnia (BBTI) is considered a short-term effective treatment for insomnia and has been implemented on online platforms.
However, the causes of insomnia are complex, and when designing related digital products, it is essential to consider the psychological and lifestyle states of individuals with insomnia, employing a user-centered approach and interactive design.
Previous research has integrated emotion tracking and an abdominal breathing game into the existing BBTI APP. This study will further incorporate the tracking of emotions and lifestyle factors (specifically diet and exercise) into a digital insomnia application, while also connecting with smartwatches and using the Experience Sampling Method (ESM) to collect data. It aims to explore the preferences of individuals with insomnia for digital tracking and examine the impact of their recorded information related to insomnia on their sleep and self-management.
The ultimate goal of this study is to enhance the existing insomnia app's features, offering innovative and convenient self-monitoring methods to help therapists better understand the condition of individuals with insomnia, while improving self-awareness and self-management. The anticipated results are expected to provide design recommendations for future digital applications related to insomnia, thereby improving the digital healthcare experience and medical efficacy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Experience Sampling Method | Experimental | Device: Personalized Experience Sampling MethodReminder times will be personalized based on participants' lifestyle patterns. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study. |
| Non-personalized Experience Sampling Method | Other | Device: Non-personalized Experience Sampling MethodReminder times will be preset by the researchers. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- Aged 18 to 64 years
- Complaints of insomnia symptoms
- Insomnia Severity Index (ISI) total score ≥ 8
- Able to express emotions and physical/mental condition normally
- Able to independently complete questionnaires
Key exclusion criteria (6 listed)
- Previously diagnosed with epilepsy
- Complaints of other sleep disorders
- Current diagnosis of a psychiatric disorder requiring treatment
- History of substance abuse or alcohol dependence
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Personalized Experience Sampling MethodReminder times will be personalized based on participants' lifestyle patterns. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study. | Device | Personalized Experience Sampling Method |
| Non-personalized Experience Sampling MethodReminder times will be preset by the researchers. Participants will wear a smartwatch daily and use the app to record emotions, diet, exercise, and sleep during the two-week study. | Device | Non-personalized Experience Sampling Method |
Primary outcome
Changes in Insomnia Severity
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Insomnia severity will be measured using the Insomnia Severity Index (ISI). The ISI consists of seven items, with each item rated from 0 to 4, resulting in a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity. Changes in ISI scores will be used to evaluate whether the BBTI app intervention improves participants' insomnia symptoms.
Changes in Sleep Quality
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep-related problems. Higher scores indicate poorer sleep quality. PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Changes in Emotional State: BBTI App self-record
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Participants' emotional state will be measured through app-based self-reports and/or standardized emotional state questionnaires. Emotional records may include daily mood, stress, anxiety, or other sleep-related psychological states. Changes in emotional state will be used to examine whether lifestyle and sleep self-monitoring through the BBTI app is associated with emotional awareness and psychological well-being.
Changes in Emotional State: Profile of Mood States
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
The Profile of Mood States (POMS) is a self-administered questionnaire that measures mood through ratings of 65 emotion terms on a five-point scale. A Total Mood Disturbance (TMD) can be calculated by adding Tension, Depression, Anger, Fatigue and Confusion scores and then subtracting the Vigour score. TMD = (Tension + Depression + Anger + Fatigue + Confusion) - Vigour.
Response Rate for Sleep-Related Lifestyle Self-Monitoring
Time frame: From Day 1 to Day 28 of the intervention period
The response rate for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the percentage of lifestyle self-monitoring reminders followed by at least one completed relevant entry. Unit of Measure：Percentage of reminders followed by a completed entry (%)
Response Latency for Sleep-Related Lifestyle Self-Monitoring
Time frame: From Day 1 to Day 28 of the intervention period
Response latency for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the average time between the delivery of a lifestyle self-monitoring reminder and the completion of a relevant entry. Unit of Measure：Minutes
Overall Self-Monitoring Completion Rate Assessed by the BBTI App
Time frame: From Day 1 to Day 28 of the intervention period
Overall self-monitoring completion rate will be assessed using app usage records from the BBTI app. This measure will be calculated as the percentage of scheduled daily self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries. Unit of Measure：Percentage of scheduled self-monitoring tasks completed (%)
Difference in Overall Self-Monitoring Completion Rate Between Personalized and Non-Personalized ESM Reminder Groups
Time frame: From Day 1 to Day 28 of the intervention period
The difference in overall self-monitoring completion rate between the personalized ESM reminder group and the non-personalized ESM reminder group will be assessed using app usage records from the BBTI app. Overall self-monitoring completion rate will be calculated as the percentage of scheduled self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries. The personalized ESM reminder group will receive reminders based on individual lifestyle patterns, while the non-personalized ESM reminder group will receive reminders at fixed times. Unit of Measure：Difference in percentage of scheduled self-monitoring tasks completed between groups (%)
Changes in Sleep-Related Lifestyle Behaviors: BBTI App Self-Record
Time frame: From Day 1 to Day 28 of the intervention period
Participants' sleep-related lifestyle behaviors will be measured through app-based self-records in the BBTI app. Lifestyle records will include meal timing and perceived fullness, caffeinated beverage intake time and amount, and exercise timing and exercise amount. Changes in sleep-related lifestyle behaviors will be used to examine participants' self-monitoring patterns and changes in lifestyle behaviors during the intervention.
Changes in Perceived Capability, Opportunity, and Motivation for Lifestyle Self-Monitoring
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Participants' perceived capability, opportunity, and motivation for insomnia-related lifestyle self-monitoring will be assessed using a COM-B-based self-report questionnaire. The questionnaire will evaluate participants' perceived capability to record lifestyle behaviors, perceived opportunity to perform self-monitoring, and motivation to continue tracking sleep-related lifestyle factors. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores. Unit of Measure：Change in mean questionnaire score
Change in Insomnia-Related Lifestyle Knowledge, Attitudes, and Behaviors
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Insomnia-related lifestyle knowledge, attitudes, and behaviors will be assessed using a self-report questionnaire. The questionnaire will evaluate participants' knowledge of sleep-related lifestyle factors, attitudes toward lifestyle self-monitoring and behavior change, and self-reported lifestyle behaviors related to insomnia management. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores. Unit of Measure：Change in mean questionnaire score
14 secondary outcomes
Brief Symptom Rating Scale-5 (BSRS-5)
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
WHO-5 Well-Being Index
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Rating Scale of Mental Effort in App Use Experience
Time frame: at baseline, Week 2, and Week 4, participants completed the in-app assessment before the task and after completing the intervention.
Average Sleep Score Collected by Smartwatch
Time frame: From Day 1 to Day 28 of the intervention period
Average Daily Step Count Collected by Smartwatch
Time frame: From Day 1 to Day 28 of the intervention period
Average Active Energy Expenditure Collected by Smartwatch
Time frame: From Day 1 to Day 28 of the intervention period
Average Heart Rate Collected by Smartwatch
Time frame: From Day 1 to Day 28 of the intervention period
Average Heart Rate Variability Collected by Smartwatch
Time frame: From Day 1 to Day 28 of the intervention period
System Usability Assessed by the System Usability Scale
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
User Experience of the BBTI App: User Experience Questionnaire
Time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.
Cognitive Load During Usability Testing Assessed by NASA-TLX
Time frame: During usability testing, Day 1
Attention Level During Prototype Operation Assessed by EEG
Time frame: During usability testing, Day 1
Heart Rate Variability During Usability Testing
Time frame: During usability testing, Day 1
Insight Formation Ability During Lifestyle Data Visualization Review
Time frame: During usability testing, Day 1
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 22 May 2026.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
Impact of New-onset Insomnia After Coronary Revascularization for Patients With Acute Myocardial Infarction
Acute Myocardial Infarction, Insomina
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Experience Sampling Method and Non-personalized Experience Sampling Method in people with Insomina and Mood Change, run by National Taipei University of Technology 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 33 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 22 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity (time frame: at baseline, Week 2, and Week 4, immediately after completion of the intervention.). The study lists 15 primary outcomes in all. 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 22 May 2026.