A Pilot Study for a Theory-based Sleep Hygiene Education

NCT07559305 | Not Yet Recruiting

• 1 other identifier: TSHE-P
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Adults

Keywords

Insomnia; Sleep Hygiene Education; Pilot Testing; Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 6

Secondary Outcomes (2)

• A 7-day Subjective Sleep Diary

  7-day before baseline and 6 week.

• Course Evaluation Form

  Week 2

Study Arms (1)

Sleep Hygiene Education

EXPERIMENTAL

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

Interventions

Sleep Hygiene Education BEHAVIORAL

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

Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

YEUNG Wing FAI, PhD

CONTACT

852-27664151; jerry-wf.yeung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

HK (1)