UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058532 |
|---|---|
| Receipt number | R000066933 |
| Scientific Title | Effect of a sleep log-based educational program on reducing social jetlag among school-aged children and adolescents: a cluster intervention trial (SLEEP-Jet) |
| Date of disclosure of the study information | 2025/07/21 |
| Last modified on | 2025/07/21 13:11:39 |
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Basic information
Public title
Sleep log-based education and entrainment program for social jetlag in school-aged children and adolescents (SLEEP-Jet)
Acronym
SLEEP-Jet
Scientific Title
Effect of a sleep log-based educational program on reducing social jetlag among school-aged children and adolescents: a cluster intervention trial (SLEEP-Jet)
Scientific Title:Acronym
SLEEP-Jet
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine whether a sleep log-based individualized sleep scheduling intervention can reduce social jetlag and improve sleep habits among school-aged children and adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in social jetlag (SJL) from baseline to 2 weeks after the intervention
Key secondary outcomes
Change in bedtime and wake-up time on weekdays and weekends
Change in sleep duration on weekdays and weekends
Change in electronic media usage time after 4:00 p.m.
Change in the proportion of students achieving the recommended sleep duration (>=9 hours for elementary school students, >=8 hours for junior high school students)
Change in subjective symptom scores (sleepiness, instability, discomfort, fatigue)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Description:
A 60-minute school-based sleep education program (including a quiz-based knowledge session and guidance on healthy sleep habits) will be delivered to students in grades 4 to 9 (elementary and junior high school).
Sleep diaries and questionnaires will be administered before and after the intervention, and individualized feedback will be provided to set personalized bedtimes and wake-up times, with the aim of improving sleep habits.
Main components:
Recording of sleep diaries for one week before and two weeks after the intervention
Preparation and distribution (on the day of the intervention) of individualized feedback sheets, showing each student's average bedtime, wake-up time, and sleep duration (displayed as graphs and figures) based on their pre-intervention sleep diary data
Based on the feedback sheet, students will be instructed to set a new target bedtime that is 15 minutes earlier than their previous average bedtime
Students will be asked to practice achieving this target (e.g., increasing sleep duration by 105 minutes per week) for two weeks
For students with late weekend wake-up times, guidance will be provided to wake up within one hour of their average weekday wake-up time (no later than 8:30 AM)
A sleep-promoting behavior checklist will be used to help each student select feasible goals for improving their sleep habits
Period and frequency:
Sleep education: Once (60-90 minutes, conducted at each school)
Sleep diary recording: One week before and two weeks after the intervention
Practice period for target behaviors: Two weeks
Evaluation (questionnaires and sleep diaries): Before and after the intervention
Notes:
Primary and secondary outcomes will be assessed using sleep diaries and questionnaires before and after the intervention.
Interventions/Control_2
Control Group
Description:
The control group will receive a single session of a standard, school-based sleep education program.
This program, conducted during class hours, provides students with accurate sleep knowledge, promotes self-assessment of sleep habits and daily routines, and encourages goal setting and implementation of target behaviors.
The main components are as follows:
Main components:
Quiz-based sleep knowledge education using PowerPoint or similar materials (approximately 40 minutes)
Explanations of the importance of sleep, strategies to improve sleep, and healthy lifestyle habits
Administration of a 12-item sleep-promoting behavior checklist and self-assessment of current habits
Each student selects one achievable target behavior from the checklist and is encouraged to practice it in daily life
Students are instructed to practice their selected target behavior for approximately two weeks
Evaluations using questionnaires are conducted at the same time points and frequency as in the intervention group
Period and frequency:
Sleep education: Once (40 minutes, conducted at each school)
Sleep diary recording: One week before and two weeks after the intervention
Practice period for target behavior: Two weeks
Evaluation (questionnaires and sleep diaries):
Before and after the intervention
Notes:
Primary and secondary outcomes are evaluated before and after the intervention using sleep diaries and questionnaires
The intervention follows a conventional program format
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Boys and girls enrolled in grades 4 through 9 (elementary grade 4 to junior high grade 3)
2) Children and students attending public elementary or junior high schools
Key exclusion criteria
1) Children and students enrolled in special needs schools
2) Schools or classes where consent for participation could not be obtained
3) Schools or classes deemed unsuitable for study implementation
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima city, Hiroshima, Japan
TEL
0824246803
tamura65@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima city, Hiroshima, Japan
TEL
0824246803
Homepage URL
tamura65@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology/Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Review Board, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima, 739-8524 JAPAN
Tel
+81-82-424-6705
ed-ken-zai@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066933
