InsomniaNCT07642479
A Theory-based Sleep Hygiene Education for Insomnia Disorder
A study testing Sleep Hygiene Education and CBT-I Apps in people with Insomnia and Adults, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Sleep Hygiene Education and CBT-I Apps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents
- Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua
- Who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire
- Scored at least 10 points in the Insomnia Severity Index
- Willing to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis
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.
Read the detailed description
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.
- Being tested
- Sleep Hygiene Education, CBT-I Apps
- Keywords
- Insomnia, Sleep hygiene education, A non-inferiority randomized controlled trial, CBT-I apps, Adults
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
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.
CBT-I AppsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education | Experimental | 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. Receives: Behavioral: Sleep Hygiene Education |
| CBT-I App | Active comparator | 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. Receives: Behavioral: CBT-I Apps |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 6, week 12 and week 24
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start10 Oct 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Wing Fai, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642479
- Sponsor's protocol ID
- SHCI
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis
- ClinicalTrials.gov ID
- NCT07642479
- Acronym / sponsor ID
- SHCI
- Keywords
- Insomnia, Sleep hygiene education, A non-inferiority randomized controlled trial, CBT-I apps, Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education | Experimental | Behavioral: Sleep Hygiene EducationParticipants 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. |
| CBT-I App | Active comparator | Behavioral: CBT-I AppsParticipants 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents
- Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua
- Who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire
- Scored at least 10 points in the Insomnia Severity Index
- Willing to give informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene EducationParticipants 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. | Behavioural | Sleep Hygiene Education |
| CBT-I AppsParticipants 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. | Behavioural | CBT-I App |
Primary outcome
The Insomnia Severity Index (ISI)
Time frame: Baseline, week 6, week 12 and week 24
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.
10 secondary outcomes
Sleep Onset Latency Measured By Sleep Diary
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
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
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
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)
Time frame: Baseline, week 6, week 12 and week 24
The Short-Form Six Dimensions (SF-6D)
Time frame: Baseline, week 6, week 12 and week 24
Sleep Onset Latency Measured By Actigraphy
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
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
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
Time frame: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education and CBT-I Apps in people with Insomnia and Adults, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wing Fai YEUNG (852-27664151, jerry-wf.yeung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Insomnia Severity Index (ISI) (time frame: Baseline, week 6, week 12 and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.