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

NCT07600840 | Enrolling By Invitation

• 1 other identifier: N202502043
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomina; Mood Change

Keywords

insomnia; bbti; Mood; Lifestyle; Digital recording,; Experience Sampling Method; Wearable Devices

Outcome Measures

Primary Outcomes (15)

• Changes in Insomnia Severity

  Insomnia severity will be measured using the Insomnia Severity Index (ISI). The ISI consists of seven items, with each item rated from 0 to 4, resulting in a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity. Changes in ISI scores will be used to evaluate whether the BBTI app intervention improves participants' insomnia symptoms.

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

• Changes in Sleep Quality

  Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep-related problems. Higher scores indicate poorer sleep quality. PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score\>5 is associated with poor sleep. The higher score means poorer sleep quality.

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

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

  Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.

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

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

  Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.

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

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

  Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

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

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

  Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.

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

• Changes in Emotional State: BBTI App self-record

  Participants' emotional state will be measured through app-based self-reports and/or standardized emotional state questionnaires. Emotional records may include daily mood, stress, anxiety, or other sleep-related psychological states. Changes in emotional state will be used to examine whether lifestyle and sleep self-monitoring through the BBTI app is associated with emotional awareness and psychological well-being.

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

• Changes in Emotional State: Profile of Mood States

  The Profile of Mood States (POMS) is a self-administered questionnaire that measures mood through ratings of 65 emotion terms on a five-point scale. A Total Mood Disturbance (TMD) can be calculated by adding Tension, Depression, Anger, Fatigue and Confusion scores and then subtracting the Vigour score. TMD = (Tension + Depression + Anger + Fatigue + Confusion) - Vigour.

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

• Response Rate for Sleep-Related Lifestyle Self-Monitoring

  The response rate for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the percentage of lifestyle self-monitoring reminders followed by at least one completed relevant entry. Unit of Measure：Percentage of reminders followed by a completed entry (%)

  From Day 1 to Day 28 of the intervention period

• Response Latency for Sleep-Related Lifestyle Self-Monitoring

  Response latency for sleep-related lifestyle self-monitoring will be assessed using app usage records from the BBTI app. Lifestyle self-monitoring entries include meal records, caffeinated beverage intake, and exercise records. This measure will be calculated as the average time between the delivery of a lifestyle self-monitoring reminder and the completion of a relevant entry. Unit of Measure：Minutes

  From Day 1 to Day 28 of the intervention period

• Overall Self-Monitoring Completion Rate Assessed by the BBTI App

  Overall self-monitoring completion rate will be assessed using app usage records from the BBTI app. This measure will be calculated as the percentage of scheduled daily self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries. Unit of Measure：Percentage of scheduled self-monitoring tasks completed (%)

  From Day 1 to Day 28 of the intervention period

• Difference in Overall Self-Monitoring Completion Rate Between Personalized and Non-Personalized ESM Reminder Groups

  The difference in overall self-monitoring completion rate between the personalized ESM reminder group and the non-personalized ESM reminder group will be assessed using app usage records from the BBTI app. Overall self-monitoring completion rate will be calculated as the percentage of scheduled self-monitoring tasks completed by participants, including sleep, emotion, diet, and exercise entries. The personalized ESM reminder group will receive reminders based on individual lifestyle patterns, while the non-personalized ESM reminder group will receive reminders at fixed times. Unit of Measure：Difference in percentage of scheduled self-monitoring tasks completed between groups (%)

  From Day 1 to Day 28 of the intervention period

• Changes in Sleep-Related Lifestyle Behaviors: BBTI App Self-Record

  Participants' sleep-related lifestyle behaviors will be measured through app-based self-records in the BBTI app. Lifestyle records will include meal timing and perceived fullness, caffeinated beverage intake time and amount, and exercise timing and exercise amount. Changes in sleep-related lifestyle behaviors will be used to examine participants' self-monitoring patterns and changes in lifestyle behaviors during the intervention.

  From Day 1 to Day 28 of the intervention period

• Changes in Perceived Capability, Opportunity, and Motivation for Lifestyle Self-Monitoring

  Participants' perceived capability, opportunity, and motivation for insomnia-related lifestyle self-monitoring will be assessed using a COM-B-based self-report questionnaire. The questionnaire will evaluate participants' perceived capability to record lifestyle behaviors, perceived opportunity to perform self-monitoring, and motivation to continue tracking sleep-related lifestyle factors. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores. Unit of Measure：Change in mean questionnaire score

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

• Change in Insomnia-Related Lifestyle Knowledge, Attitudes, and Behaviors

  Insomnia-related lifestyle knowledge, attitudes, and behaviors will be assessed using a self-report questionnaire. The questionnaire will evaluate participants' knowledge of sleep-related lifestyle factors, attitudes toward lifestyle self-monitoring and behavior change, and self-reported lifestyle behaviors related to insomnia management. The change score will be calculated as the difference between baseline and post-intervention questionnaire scores. Unit of Measure：Change in mean questionnaire score

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

Secondary Outcomes (14)

• Brief Symptom Rating Scale-5 (BSRS-5)

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

• WHO-5 Well-Being Index

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

• Rating Scale of Mental Effort in App Use Experience

  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

  From Day 1 to Day 28 of the intervention period

• Average Daily Step Count Collected by Smartwatch

  From Day 1 to Day 28 of the intervention period

Study Arms (2)

Personalized Experience Sampling Method

EXPERIMENTAL

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: Personalized Experience Sampling Method

Non-personalized Experience Sampling Method

OTHER

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.

Device: Non-personalized Experience Sampling Method

Interventions

Personalized Experience Sampling Method DEVICE

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.

Personalized Experience Sampling Method

Non-personalized Experience Sampling Method DEVICE

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.

Non-personalized Experience Sampling Method

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taipei University of Technology: lead

Study Sites (1)

National Taipei University of Technology

Taipei, Taipei, 10608, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 22, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)