An interventional study of Sleep Hygiene Education in Insomnia and Adults, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Insomnia is a prevalent sleep disorder associated with substantial negative health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological and psychological treatments exist, fewer than half of individuals with insomnia seek professional treatment, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. However, previous studies have often underestimated the efficacy of SHE by using it as a passive control condition rather than an active, structured intervention. To address this limitation, the proposed pilot study aims to evaluate the feasibility and effectiveness of a theory-based, structured SHE program integrated with behavior change techniques.
Insomnia is a prevalent sleep disorder associated with substantial negative health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological (e.g., hypnotics) and psychological treatments (e.g., cognitive behavioral therapy for insomnia, CBT-I) are available, both local and international surveys indicate that fewer than 50% of individuals with insomnia seek treatment. This treatment gap highlights the need to develop effective non-pharmacological interventions that are both accessible and acceptable to individuals with insomnia.
Sleep hygiene education (SHE) represents a potentially suitable intervention to address this unmet need. SHE is an educational approach that encompasses a range of lifestyle and environmental recommendations aimed at optimizing sleep quality and duration, such as maintaining a regular sleep-wake schedule, avoiding substances (e.g., caffeine, nicotine, and alcohol) and daytime napping, limiting stimulating bedtime activities, creating an optimal bedroom environment, and adopting appropriate diet and exercise habits etc. Given its simplicity, low cost, accessibility, and ease of delivery and mastery, SHE holds promise as a non-pharmacological strategy for insomnia management.
Despite these advantages, SHE is not typically recommended as a stand-alone treatment for sleep-vulnerable populations, as it is often perceived to be less effective than CBT-I or mindfulness-based therapies. Notably, the efficacy of SHE may be underestimated. In many prior studies, SHE has been used primarily as a passive control condition to account for nonspecific treatment effects, resulting in its active therapeutic components being largely overlooked.
Advancing SHE beyond a simple advice-giving modality to a structured, theory-informed intervention may enhance its effectiveness by ensuring that its content is not only informative but also practicable and behaviorally achievable. Integrating SHE with evidence-based behavior change techniques may further equip participants with the skills necessary to initiate and sustain meaningful behavioral change. Accordingly, this pilot study aims to examine the feasibility and preliminary effectiveness of a theory-based SHE program previously developed by our team.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 11 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2 hours group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each. During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices and will develop individualized behavior change plans to support sustained sleep hygiene implementation. The subsequent telephone consultations will reinforce adherence to these plans through review of progress, discussion of barriers, and provision of tailored feedback. To obtain qualitative feedback on the acceptability of the intervention, a focus group interview lasting approximately 1 hour will be conducted after completion of the second educational session.
Behavioral: Sleep Hygiene Education
Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2 hours group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each. During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices and will develop individualized behavior change plans to support sustained sleep hygiene implementation. The subsequent telephone consultations will reinforce adherence to these plans through review of progress, discussion of barriers, and provision of tailored feedback. To obtain qualitative feedback on the acceptability of the intervention, a focus group interview lasting approximately 1 hour will be conducted after completion of the second educational session.
Also known as: SHE
Insomnia Severity Index (ISI)
The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia. Total score will be used.
Time frame: Baseline, week 6
A 7-day Subjective Sleep Diary
The subjects will be asked to record their daily sleeping-waking schedule using a standard sleep diary for 7 days, and Sleep parameters, such as sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), and sleep duration (TST) will be measured.
Time frame: 7-day before baseline and 6 week.
Course Evaluation Form
Participants will be asked to complete a course evaluation form after completing the two SHE sessions. The evaluation consists of five domains comprising a total of 28 items, each rated on a 5-point Likert scale. Total scores range from 28 to 140, with higher scores indicating greater satisfaction with the course content and educational materials.
Time frame: Week 2
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
The Hong Kong Polytechnic University