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SleepRESTNCT07056179

Brief Behavioral Intervention to Maintain Sleep Regularity in Young Adults Over the Christmas Break

A study testing Brief behavioural intervention and Health education in people with Sleep, run by Hong Kong Baptist University at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will employ a randomized controlled trial design to investigate the effects of a brief behavioral intervention that includes (1) self-recording of a regularity-focused sleep diary, (2) 10 strategies for maintaining sleep regularity, and (3) a sleep education information sheet on the maintenance of sleep… Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Brief behavioural intervention and Health education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
236 participants
Where
1 siteHong Kong
Study dates
1 Nov 2025to 31 Jan 2026
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 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Young adults aged 18-24 years;
  • Will stay in Hong Kong during the study period;
  • Will not engage in any activities that require a fixed sleep or wake-up time (e.g., work or study during the holiday period) as these activities could regularize the sleep schedule and potentially contaminate the results.

Who cannot join

  • Have been in a different time zone within two weeks before the baseline assessment;
  • Diagnosed with circadian rhythm disorders such as delayed sleep-wake phase disorder (DSWD), advanced sleep-wake phase disorder (ASWD), irregular sleep-wake rhythm disorder (ISWRD), and non-24-hour sleep-wake rhythm disorder (N24WSD);
  • Diagnosed with sleep disorders that directly/indirectly interfere with sleep regularity (e.g., insomnia, sleep apnea);
  • Use of medications or treatment that may influence sleep regularity (e.g., hypnotics, antidepressants);
  • Diagnosed with serious physical or mental diseases such as cancer, end-stage liver or kidney diseases, schizophrenia, and psychosis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Danny YU, PhD contact

852-34115309

dannyu@hkbu.edu.hk

Hong Kong1 site
  • Hong Kong Baptist University

    Kowloon City, Kowloon Tong

    Danny Yu, PhD, 85234115309, dannyu@hkbu.edu.hk

Other trials in Hong Kong

About this study

Official title: REST Trial: Effects of a Brief Behavioral Intervention to Maintain Sleep Regularity in Young Adults Over the Christmas Break

This study will employ a randomized controlled trial design to investigate the effects of a brief behavioral intervention that includes (1) self-recording of a regularity-focused sleep diary, (2) 10 strategies for maintaining sleep regularity, and (3) a sleep education information sheet on the maintenance of sleep regularity in young adults during the Christmas break.

Conditions
Sleep
Being tested
Brief behavioural intervention, Health education
Keywords
sleep regularity, brief behavioral intervention, young adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief behavioural interventionBehavioural

    Participants will receive a brief behavioural intervention comprising a regularity-focused sleep diary, 10 tips for maintaining sleep regularity, and a sleep education information sheet. The regularity-focused sleep diary is designed to emphasize in-bed and out-of-bed times, drawing participants' attention to their sleep regularity. Participants will be provided with a yellow marker to highlight their sleep periods. The 10 tips for maintaining sleep regularity include establishing a consistent out-of-bed time, using natural light to regulate the circadian clock, adjusting mealtimes, etc. The sleep education sheet contains information on reducing caffeine intake in the afternoon, limiting screen time before bed, etc.

  • Health educationBehavioural

    Participants will receive general health information without specific emphasis on sleep, such as weight control, smoking cessation, etc.

Study groups in NCT07056179
Study groupRoleWhat they receive
Brief behavioural intervention groupExperimentalParticipants will receive a brief behavioral intervention comprising a regularity-focused sleep diary, 10 tips for maintaining sleep regularity, and a sleep education information sheet. The regularity-focused sleep diary is designed to emphasize in-bed and out-of-bed times, drawing participants' attention to their sleep regularity. Participants will be provided with a yellow marker to highlight their sleep periods. The 10 tips for maintaining sleep regularity include establishing a consistent out-of-bed time, using natural light to regulate the circadian clock, adjusting mealtimes, etc. The sleep education sheet contains information on reducing caffeine intake in the afternoon, limiting screen time before bed, etc.
Receives: Behavioral: Brief behavioural intervention
Health education control groupPlacebo comparatorParticipants will receive general health information without specific emphasis on sleep, such as weight control, smoking cessation, etc.
Receives: Behavioral: Health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep regularity

    Sleep regularity will be measured by the validated Chinese version of sleep regularity questionnaire (SRQ), which shows excellent reliability and validity. SRQ consists of six items focusing on two dimensions, circadian regularity and sleep continuity regularity. Each item is rated on a scale ranging from 0 (not at all) to 4 (very much) in terms of the degree to which they agreed with each statement, with higher scores indicating higher sleep regularity.

    Measured: From baseline assessment to the end of intervention at 3 weeks

Secondary outcomes (3)
  1. Severity of depression

    The severity of depression will be measured by the Patient Health Questionnaire - 9 item (PHQ-9). It asks participants how often they experienced depressive symptoms over the past 2 weeks. PHQ-9 comprises 5 categories: 0-4 indicates minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and ≥20 severe depression.

    Measured: From baseline assessment to the end of intervention at 3 weeks

  2. Severity of anxiety

    The severity of anxiety will be measured by the Generalized Anxiety Disorder - 7 item (GAD-7). The cut-off scores of GAD-7 are: 0-4 indicates minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and ≥15 severe anxiety.

    Measured: From baseline assessment to the end of intervention at 3 weeks

  3. Work and social functioning

    Work and social functioning will be assessed using the Work and Social Adjustment Scale (WSAS), a 5-item instrument in which each item is rated on a 9-point Likert scale (0 = not at all, 8 = very severely). The total WSAS score ranges from 0 to 40, with lower scores indicating better functioning.

    Measured: From baseline assessment to the end of intervention at 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07056179
Sponsor's protocol ID
20250606_REST
Other IDs
REC/24-25/0554
Acronym
REST
Status last verified
Jul 2025
First submitted
7 Jul 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol, statistical analysis plan, and analytic code will be deposited in an open registry when the study is published.

Questions about this trial

What is this clinical trial studying?

A study testing Brief behavioural intervention and Health education in people with Sleep, run by Hong Kong Baptist 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 3 inclusion and 5 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 11 Jul 2025. 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. Some participants in this study may receive a placebo. 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 Danny YU, PhD (852-34115309, dannyu@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep regularity (time frame: From baseline assessment to the end of intervention at 3 weeks). 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 11 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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