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

NCT ID: NCT07056179

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Due to the nature of the intervention, participants cannot be blinded. However, they will be unaware of the true aim of the study and will be informed that the intervention is intended to enhance overall well-being. Outcome measures will be administered by research personnel who are blinded to group allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief behavioural intervention group

Participants 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.

Group Type EXPERIMENTAL

Brief behavioural intervention

Intervention Type BEHAVIORAL

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 education control group

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

Group Type PLACEBO_COMPARATOR

Health education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief behavioural intervention

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.

Intervention Type BEHAVIORAL

Health education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Young adults aged 18-24 years;
2. Will stay in Hong Kong during the study period;
3. 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.

Exclusion Criteria

1. Have been in a different time zone within two weeks before the baseline assessment;
2. 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);
3. Diagnosed with sleep disorders that directly/indirectly interfere with sleep regularity (e.g., insomnia, sleep apnea);
4. Use of medications or treatment that may influence sleep regularity (e.g., hypnotics, antidepressants);
5. Diagnosed with serious physical or mental diseases such as cancer, end-stage liver or kidney diseases, schizophrenia, and psychosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

YU Jucheng

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Danny YU, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hong Kong Baptist University

Kowloon City, Kowloon Tong, Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Danny YU, PhD

Role: CONTACT

852-34115309

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Danny Yu, PhD

Role: primary

85234115309

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/24-25/0554

Identifier Type: OTHER

Identifier Source: secondary_id

20250606_REST

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep in Adolescents - Pilot Study
NCT05703061 RECRUITING NA
Sleep Measurement Study
NCT04288557 COMPLETED
Self-Management of Sleep Among Older Adults
NCT03837249 COMPLETED EARLY_PHASE1
INvestigating the Value of Early Sleep Therapy
NCT06294041 NOT_YET_RECRUITING NA
Brief Sleep Intervention for Bedtime Resistance
NCT06970392 NOT_YET_RECRUITING NA
Sleep and Resistance Exercise
NCT06606626 COMPLETED NA