UMIN-CTR Clinical Trial

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