A Theory-based Sleep Hygiene Education for Insomnia Patients

Starting soon · Not applicable

Conditions studied: Insomnia, Adults

In brief

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.

Key facts

Study ID

NCT07559305

Run by

The Hong Kong Polytechnic University

People needed

10

Starts

2026-05-10

Expected to finish

2026-07-31

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hong Kong residents
• Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua
• Fulfilled the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire. The criteria included having difficulties falling asleep, staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months
• Scored at least 10 points in the Insomnia Severity Index (ISI)
• Willing to give informed consent

You may not qualify if…

• Any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV
• Other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment
• Any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia
• Taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders
• Impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions
• Pregnant
• Shift work

Where it is running

• School of Nursing, The Hong Kong Polytechnic University — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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