UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060234 |
|---|---|
| Receipt number | R000068895 |
| Scientific Title | Effects of a School-Based Sleep Education Program Incorporating Individualized Goal Setting: A Cluster-Based Quasi-Experimental Study |
| Date of disclosure of the study information | 2025/12/30 |
| Last modified on | 2025/12/30 12:15:29 |
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Basic information
Public title
Evaluation of a School-Based Sleep Education Program for Adolescents
Acronym
SLEEP-EDU
Scientific Title
Effects of a School-Based Sleep Education Program Incorporating Individualized Goal Setting: A Cluster-Based Quasi-Experimental Study
Scientific Title:Acronym
SLEEP-EDU
Region
| Japan |
Condition
Condition
Sleep insufficiency, irregular sleep habits, and daytime sleepiness
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of a school-based sleep education program on sleep behaviors, sleep duration, and daytime sleepiness among junior high school students. In particular, this study aimed to evaluate whether an intervention incorporating individualized behavioral goal setting could promote improvements and maintenance of healthy sleep habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weekday sleep duration assessed by self-administered questionnaire at baseline, 4 weeks, and 8 weeks after the intervention.
Key secondary outcomes
Bedtime and wake-up time on weekdays and weekends
Social jetlag
Daytime sleepiness assessed by the Pediatric Daytime Sleepiness Scale (PDSS-J)
Engagement in sleep-promoting behaviors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 60-minute school-based sleep education program consisting of a lecture on sleep health, self-assessment of sleep habits, and individualized goal setting using a structured checklist. Follow-up assessments were conducted at 4 and 8 weeks after the intervention.
Interventions/Control_2
Wait-list control group. Participants received no intervention during the study period and were offered the same educational program after completion of follow-up assessments.
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
| 12 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students enrolled in participating junior high schools
Provision of written informed consent from both students and their parents or guardians
Key exclusion criteria
None
Target sample size
1400
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
739-8524
Address
1-1-1Kagamiyama, Higashi-Hiroshima
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
739-8524
Address
1-1-1Kagamiyama, Higashi-Hiroshima
TEL
0824246803
Homepage URL
tamura65@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Research Ethics Committee, Hiroshima International University
Address
555-36 Gakuendai, Kurose, Higashihiroshima, Hiroshima 739-2695, Japan
Tel
0823-70-4862
t-hideki@hirokoku-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 | 12 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_menu_form.cgi?recptno=R000068895
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_menu_form.cgi?recptno=R000068895
Number of participants that the trial has enrolled
1323
Results
The present study examined the effects of a school-based sleep education program among adolescents.
The intervention group demonstrated earlier bedtimes, increased sleep duration, reduced social jetlag, and decreased daytime sleepiness.
These findings suggest that a behavioral intervention incorporating individualized goal setting may contribute to improvements in sleep-related behaviors.
Detailed results are currently under review for publication in a peer-reviewed journal.
Results date posted
| 2025 | Year | 12 | Month | 30 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The results of this study are currently under review for publication in a peer-reviewed journal. Therefore, detailed results have not yet been publicly released.
Date of the first journal publication of results
Baseline Characteristics
Participants consisted of 1,323 junior high school students aged 12-15 years, with sex and grade distributions reflecting those of the participating schools.
Participant flow
Students who provided informed consent completed baseline assessments and were followed as either intervention or wait-list control groups. Follow-up assessments were conducted at 4 and 8 weeks post-intervention.
Adverse events
No adverse events related to the intervention were reported.
Outcome measures
The primary outcome was weekday sleep duration. Secondary outcomes included bedtime, social jetlag, daytime sleepiness, and sleep-promoting behaviors.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was approved by the institutional ethics committee in 2012. Due to limitations in record archiving at that time, the exact approval date could not be definitively confirmed. Therefore, the date of February 28, 2012 is provided as an approximate approval date based on available documentation and institutional records.
Management information
Registered date
| 2025 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068895
