UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027587 |
|---|---|
| Receipt number | R000031621 |
| Scientific Title | School-based Sleep Hygiene Education Program for Adolescents in Japan |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/08/01 12:00:57 |
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Basic information
Public title
School-based Sleep Hygiene Education Program for Adolescents in Japan
Acronym
The effect of sleep hygiene education on adolescents
Scientific Title
School-based Sleep Hygiene Education Program for Adolescents in Japan
Scientific Title:Acronym
The effect of sleep hygiene education on adolescents
Region
| Japan |
Condition
Condition
Sleep disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of using sleep hygiene education programs given to Japanese high school students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
sleep disorder after 1 year
Key secondary outcomes
mental health after 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:
sleep hygiene education program.
Interventions/Control_2
Control group:
No sleep hygiene education program.
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
| 15 | years-old | <= |
Age-upper limit
| 17 | years-old | > |
Gender
Male and Female
Key inclusion criteria
First grader of high school in 2015
Key exclusion criteria
Difficult to understand information about the study
Students with insomnia
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kaneita |
Organization
Faculty of Medicine, Oita University.
Division name
Department of Public Health and Epidemiology
Zip code
8795593
Address
1-1 Hasama-machi Idaigaoka, Yufu City, Oita 879-5593
TEL
097-586-5735
kosyu1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kaneita |
Organization
Faculty of Medicine, Oita University.
Division name
Department of Public Health and Epidemiology
Zip code
8795593
Address
1-1 Hasama-machi Idaigaoka, Yufu City, Oita 879-5593
TEL
0975865735
Homepage URL
kosyu1@oita-u.ac.jp
Sponsor or person
Institute
Department of Public Health and Epidemiology, Faculty of Medicine, Oita University.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Faculty Of Medicine
Address
1-1 Idaigaoka,Hasama-machi,Yufu City
Tel
097-549-4411
kosyu1@oita-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
| 2017 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
