Набор по приглашению NCT07600840

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

Без фазы С лечением Insomina Mood Change

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Personalized Experience Sampling Method, Non-personalized Experience Sampling Method.
Кому может быть актуально: Состояния в реестре: Insomina, Mood Change. Базовые параметры: 18 лет — 64 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

Устройство 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.
Устройство 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.

Первичные конечные точки

Changes in Insomnia Severity [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Sleep Quality [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL) [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Sleep parameters from sleep logs: after sleep onset(WASO) [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Sleep parameters from sleep logs: total sleep time(TST) [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Sleep parameters from sleep logs: sleep efficiency(SE) [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Emotional State: BBTI App self-record [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Changes in Emotional State: Profile of Mood States [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Response Rate for Sleep-Related Lifestyle Self-Monitoring [Срок оценки: From Day 1 to Day 28 of the intervention period]
Response Latency for Sleep-Related Lifestyle Self-Monitoring [Срок оценки: From Day 1 to Day 28 of the intervention period]

Вторичные конечные точки (12)

Brief Symptom Rating Scale-5 (BSRS-5) [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
WHO-5 Well-Being Index [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Rating Scale of Mental Effort in App Use Experience [Срок оценки: 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 [Срок оценки: From Day 1 to Day 28 of the intervention period]
Average Daily Step Count Collected by Smartwatch [Срок оценки: From Day 1 to Day 28 of the intervention period]
Average Active Energy Expenditure Collected by Smartwatch [Срок оценки: From Day 1 to Day 28 of the intervention period]
Average Heart Rate Collected by Smartwatch [Срок оценки: From Day 1 to Day 28 of the intervention period]
Average Heart Rate Variability Collected by Smartwatch [Срок оценки: From Day 1 to Day 28 of the intervention period]
System Usability Assessed by the System Usability Scale [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
User Experience of the BBTI App: User Experience Questionnaire [Срок оценки: at baseline, Week 2, and Week 4, immediately after completion of the intervention.]
Cognitive Load During Usability Testing Assessed by NASA-TLX [Срок оценки: During usability testing, Day 1]
Attention Level During Prototype Operation Assessed by EEG [Срок оценки: During usability testing, Day 1]

Критерии участия

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