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

Official title

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

Overview

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.

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.

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Taiwan · 1 center

• National Taipei University of Technology — Taipei

Identifiers

NCT: NCT07600840 · N202502043

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗