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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027587
Receipt No. 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

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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
Email 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
Email kosyu1@oita-u.ac.jp

Sponsor
Institute Department of Public Health and Epidemiology, Faculty of Medicine, Oita University.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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