An interventional study of Sleep Hygiene Education and CBT-I Apps in Insomnia and Adults, sponsored by The Hong Kong Polytechnic University. Not yet recruiting 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
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Among 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University — 8 open to participants now, 8 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · The Hong Kong Polytechnic University.
Among the 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University, this one has the largest planned enrollment of the 19 interventional ones that give a count, is one of 8 that started in 2026, is one of 19 with no phase, and was the 17th registered.
2,728 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →8 of the 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University are open now, in 2 countries. Recruiting first, the newest first:
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18–60 · Healthy volunteers
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18–60 · Healthy volunteers
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18–60 · Healthy volunteers
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18+
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 8 started in 2026.
This study's planned enrollment of 264 is above the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 68 across the 19 interventional studies, 80 across the 3 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
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The Hong Kong Polytechnic University is the lead sponsor of 681 studies on the registry; 259 are open to participants now.
4 of the studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07826650The Hong Kong Polytechnic UniversityThe Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls | 2027-08-31 |
| NCT07827664The Hong Kong Polytechnic UniversityThe Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain | 2027-08-31 |
| NCT07827677The Hong Kong Polytechnic UniversityThe Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia | 2027-08-31 |
| NCT07588035The Hong Kong Polytechnic UniversityArtificial Intelligence (AI)-Assisted Sleep Intervention for Insomnia in Older Adults With Subjective Cognitive Decline | 2027-09-01 |
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Among the 22 studies in Sleep Initiation and Maintenance Disorders by The Hong Kong Polytechnic University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Insomnia is a prevalent sleep disorder associated with numerous adverse health outcomes, including fatigue, irritability, and impaired daytime functioning. Despite the availability of effective pharmacological and psychological treatments, relatively few individuals with insomnia seek professional help, 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. Building on our previously registered pilot-testing protocol, this study aims to examine the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community population. Furthermore, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as cognitive behavioral therapy for insomnia (CBT-I) delivered via digital applications. Therefore, this study will also compare the effectiveness of theory-based SHE with a CBT-I app using a three-arm randomized controlled trial design.
Insomnia is a prevalent sleep disorder associated with substantial adverse 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 underscores the need for effective non-pharmacological interventions that are both accessible and acceptable.
Sleep hygiene education (SHE) represents a potentially suitable approach to address this unmet need. SHE is an educational intervention encompassing a range of lifestyle and environmental recommendations to optimize sleep quality and duration. These include maintaining a regular sleep-wake schedule, avoiding substances such as caffeine, nicotine, and alcohol, limiting daytime napping and stimulating activities before bedtime, optimizing the sleep environment, and adopting appropriate dietary and exercise habits etc. Given its simplicity, low cost, accessibility, and ease of delivery and adoption, 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 individuals with sleep problems, as it is often perceived to be less effective than CBT-I or mindfulness-based interventions, with consistently small effect sizes reported. However, these findings should be interpreted with caution. In many previous studies, SHE has primarily been used as a passive control condition to account for nonspecific treatment effects, thereby underexploiting its active therapeutic potential. Moving SHE beyond a simple advice-giving modality to a structured, theory-informed approach may optimize its effectiveness by ensuring its content is informative and promising. Integrating SHE with established behavior change techniques may better equip individuals with the skills needed to initiate and sustain meaningful behavioral change.
Building on our previously registered pilot-testing protocol, this study aims to evaluate the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community sample. In addition, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as digitally delivered CBT-I. This study will also examine whether a theory-based SHE program is a cost-effective approach for reducing insomnia severity in adults with insomnia disorder compared with a CBT-I app and a no-intervention control. To address these objectives, a three-arm randomized controlled trial will be conducted to compare the relative effectiveness of these interventions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2-hour 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 implementation of sleep hygiene practices. The subsequent telephone consultations will reinforce adherence to these plans by reviewing progress, discussing barriers, and providing tailored feedback.
Behavioral: Sleep Hygiene Education
Participants in this group will receive a CBT-I program consisting of six weekly modules delivered in the Chinese language through a smartphone application proACT-S. The duration of each module is around 45 to 60 min with interactive features. The self-help CBT-I treatment content in proACT-S is based on the Chinese translated version of a well-established CBT-I treatment manual. The self-help CBT-I treatment content is designed to alter dysfunctional cognitive beliefs and maladaptive behaviors that perpetuate insomnia. The self-help CBT-I treatment content CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia.
Behavioral: CBT-I Apps
Participants in this group will receive no intervention from the study. They will be provided with the same SHE program and CBT-I apps after the follow-up period. Waitlist control is chosen as previous surveys have revealed that almost half of individuals with clinical insomnia refrain from seeking any treatment. Therefore, the waitlist control group reflects the typical help-seeking behavior of those coping with insomnia, thus providing a more realistic comparison for our study.
Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2-hour 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 implementation of sleep hygiene practices. The subsequent telephone consultations will reinforce adherence to these plans by reviewing progress, discussing barriers, and providing tailored feedback.
Participants in this group will receive a CBT-I program consisting of six weekly modules delivered in the Chinese language through a smartphone application proACT-S. The duration of each module is around 45 to 60 min with interactive features. The self-help CBT-I treatment content in proACT-S is based on the Chinese translated version of a well-established CBT-I treatment manual. The self-help CBT-I treatment content is designed to alter dysfunctional cognitive beliefs and maladaptive behaviors that perpetuate insomnia. The self-help CBT-I treatment content CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia.
The 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, week 12 and week 24
Sleep Onset Latency Measured By Sleep Diary
Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary. Sleep onset latency (SOL) is defined as the time (minutes) taken to fall asleep after going to bed. The average value over 7 consecutive nights will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Wake After Sleep Onset Measured By Sleep Diary
Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary. Wake after sleep onset (WASO) is defined as the total time (minutes) awake after initial sleep onset during the night. The average value over 7 consecutive nights will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Sleep Efficiency Measured By Sleep Diary
Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary. Sleep efficiency (SE) is defined as the percentage of time in bed spent asleep. The average percentage over 7 consecutive nights will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Total Sleep Time Measured By Sleep Diary
Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary. Total sleep time (TST) is defined as the total duration (minutes) of sleep per night. The average value over 7 consecutive nights will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).
Time frame: Baseline, week 6, week 12 and week 24
The Short-Form Six Dimensions (SF-6D)
The Short-Form Six Dimensions (SF-6D) will be used to assess the quality of life. The score ranges from 0 (worst quality of life) to 1 (perfect quality of life), with higher scores reflecting better overall health-related quality of life.
Time frame: Baseline, week 6, week 12 and week 24
Sleep Onset Latency Measured By Actigraphy
Sleep onset latency (SOL) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK). Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point. SOL will be recorded in minutes, and the mean value over the 7-night period will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Wake After Sleep Onset Measured By Actigraphy
Wake after sleep onset (WASO) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK). Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point. WASO will be recorded in minutes, and the mean value over the 7-night period will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Sleep Efficiency Measured By Actigraphy
Sleep efficiency (SE) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK). Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point. SE will be expressed as a percentage, and the mean value over the 7-night period will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Total Sleep Time Measured By Actigraphy
Total sleep time (TST) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK). Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point. TST will be recorded in minutes, and the mean value over the 7-night period will be calculated.
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Start is estimated for Oct 2026; primary completion for Jan 2028, 14 months later.
Of 1,211 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 14 months is close to that.
Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →
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