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A Theory-based Sleep Hygiene Education for Insomnia Patients

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Completed without a posted recruiting period Show 6 more changesShow less
    • Final enrollment: 11 participants (planned 10)
    • Primary completion date changed from estimate of Jun 30, 2026 to Jun 17, 2026
    • Study completion date changed from estimate of Jul 31, 2026 to Jul 30, 2026
    • Start date changed from estimate of May 10, 2026 to May 13, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Secondary endpoints: details revised at 1 of 2 entries
    • Study title shortened, about 1 word
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07559305
Lead Sponsor The Hong Kong Polytechnic University
Conditions
(from sponsor)		 Insomnia, Adults
Related terms Sleep Initiation and Maintenance Disorders
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov