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临床试验/NCT07600840
NCT07600840Enrolling By Invitation不适用

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

National Taipei University of Technology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月16日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • 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

研究者

发起方
National Taipei University of Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ko-Chiu, Wu

Principal Investigator

National Taipei University of Technology

研究点 (1)

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