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NCT07600840

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

Sponsor: National Taipei University of Technology

View on ClinicalTrials.gov

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.

Official title: Integrating Smart Wearable Devices Into Digital Insomnia Treatment Applications: An Exploration of Combining Emotional and Lifestyle Records

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-16

Completion Date

2027-06

Last Updated

2026-05-22

Healthy Volunteers

Yes

Conditions

Insomina Mood Change

Interventions

DEVICE

Personalized Experience Sampling Method

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.

DEVICE

Non-personalized Experience Sampling Method

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.

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

Locations (1)

National Taipei University of Technology

Taipei, Taipei, Taiwan