Integrating Smart Wearable Devices Into Digital Insomnia Treatment Applications: An Exploration of Combining Emotional and Lifestyle Records
Sponsor: National Taipei University of Technology
Trial Details
| Condition | Insomina, Mood Change |
| Intervention | Personalized Experience Sampling Method; Non-personalized Experience Sampling Method |
| Phase | NA |
| Status | Unknown |
| Participants | 60 |
| Est. Completion | 1 June 2027 |
| Last Updated | 22 May 2026 |
Primary Outcome
Changes in Insomnia Severity; Changes in Sleep Quality; Changes in Sleep parameters from sleep logs: sleep onset latency(SOL); Changes in Sleep parameters from sleep logs: after sleep onset(WASO); Changes in Sleep parameters from sleep logs: total sleep time(TST); Changes in Sleep parameters from sleep logs: sleep efficiency(SE); Changes in Emotional State: BBTI App self-record; Changes in Emotional State: Profile of Mood States; Response Rate for Sleep-Related Lifestyle Self-Monitoring; Response Latency for Sleep-Related Lifestyle Self-Monitoring; Overall Self-Monitoring Completion Rate Assessed by the BBTI App; Difference in Overall Self-Monitoring Completion Rate Between Personalized and Non-Personalized ESM Reminder Groups; Changes in Sleep-Related Lifestyle Behaviors: BBTI App Self-Record; Changes in Perceived Capability, Opportunity, and Motivation for Lifestyle Self-Monitoring; Change in Insomnia-Related Lifestyle Knowledge, Attitudes, and Behaviors
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria Experimental Phase 1 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 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 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 Exclusion Criteria * 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 Sites
Countries
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