Ireland
--:--IST
Recruiting Not applicable

Digital Sleep Program for College Students with Insomnia

NCT06853106 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2024-04-24
Last updated
2025-02-28

Condition(s) studied

Insomnia

Investigational drug(s) / intervention(s)

Waitlist control groupdigital-based multimodal sleep management program

Waitlist control group: The participants in the waitlist control group will be informed that they are on a waiting list during the intervention period, serving as a no-treatment control. They will receive the sleep intervention (i.e., the digital-based sleep management program) four weeks after the intervention period is completed.

digital-based multimodal sleep management program: The digital-based multimodal sleep management program consists of (1) sleep hygiene education, (2) sleep restriction, and (3) mindfulness breathing exercises. The program is internet-integrated and delivered via Google Meet, with 45-minute weekly sessions over four weeks. To increase participants' adherence to the sleep management program , the course instructor will request the participants to record their daily sleep diaries (time to bed, time to sleep, wake time during sleep and wake time) and sleep journals(practices of sleep hygiene, sleep restriction and mindfulness breathing exercise) in the mobile app for at least five consecutive days each week.

Study summary

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.

Eligibility

Sex
ALL
Min age
18 Years
Max age
26 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Registered as a full-time student 2. Aged 18 to 26 years old 3. Experiencing insomnia for at least three months 4. Currently own and use a personal mobile device 5. Ability to read and speak Chinese 6. Not taking hypnotics, sedatives, or antidepressants 7. Not pregnant or lactating Exclusion Criteria: 1. Using a smartphone model that cannot support the app 2. Currently using other sleep program apps 3. Meeting a STOP-BANG score of ≥3

Primary outcome measure(s)

  • Insomnia Severity:The Insomnia Severity Index (ISI) — T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.
    The Insomnia Severity Index (ISI) consists of seven items that assess the current perception of the severity of three insomnia symptoms. Each item is rated on a 5-point Likert scale, with the total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia.

Trial sites (1)

FacilityCityRegionStatus
Taipei Medicine University Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06853106 on ClinicalTrials.gov ↗ ← All trials in Taiwan