By InvitationNot Applicable

Integrating Smart Wearable Device Into Digital Insomnia Treatment Application: Exploration of Combining Emotional and Lifestyle Records

Taiwan60 participantsStarted 2026-04-16

Plain-language 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. 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Insomnia Severity

Timeframe: at baseline, Week 2, and Week 4, immediately after completion of the intervention.

Changes in Sleep Quality

Timeframe: at baseline, Week 2, and Week 4, immediately after completion of the intervention.

Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)

Timeframe: at baseline, Week 2, and Week 4, immediately after completion of the intervention.

Changes in Sleep parameters from sleep logs: after sleep onset(WASO)

Timeframe: at baseline, Week 2, and Week 4, immediately after completion of the intervention.

Changes in Sleep parameters from sleep logs: total sleep time(TST)

Timeframe: at baseline, Week 2, and Week 4, immediately after completion of the intervention.

Changes in Sleep parameters from sleep logs: sleep efficiency(SE)

Timeframe: at baseline, Week 2, and Week 4, immediately after completion of the intervention.

Trial details

NCT IDNCT07600840

SponsorNational Taipei University of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

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