UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of the tailored sleep hygiene intervention on the sleep disturbance, absenteeism, and presenteeism among adolescent: A randomized controlled study.
Acronym	The efficacy of the tailored sleep hygiene intervention on the sleep disturbance, absenteeism, and presenteeism among adolescent: A randomized controlled study.
Scientific Title	The efficacy of the tailored sleep hygiene intervention on the sleep disturbance, absenteeism, and presenteeism among adolescent: A randomized controlled study.
Scientific Title:Acronym	The efficacy of the tailored sleep hygiene intervention on the sleep disturbance, absenteeism, and presenteeism among adolescent: A randomized controlled study.
Region	Japan

Condition
Condition	Sleep disturbance and sleep problems
Classification by specialty	Psychosomatic Internal Medicine Psychiatry Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of tailored sleep hygiene intervention in adolescent with absenteeism or presenteeism suffering from a sleep disturbance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Absenteeism from the intervention to the end of the school year.
Key secondary outcomes	1) Sleep measurements (PSQI, PDSS, SJL, etc.) 2) Absenteeism after the next school year of the intervention 3) The rate of school promotion, holdover, and leaving 4) Presenteeism 5) School achievement 6) Daytime sleepiness and snooze 7) The difference of the intervention efficacy between by a specialist and by a non-specialist

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group
Interventions/Control_2	Sham control group
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	25 years-old >
Gender	Male and Female
Key inclusion criteria	To satisfy ALL the criteria shown below: (1) Belonging to any kind of school, or being equal or over 12 years old (except elementary school students) and under 25 years old when registered to the study (2) Being suffered from sleep disturbance or sleep problem (ex. PSQI>5.5, SJL>2h, subjective insomnia) (3) Having absenteeism or presenteeism
Key exclusion criteria	To satisfy ANY of the criteria shown below: (1) Those who disagreed with the study. (2) Those whose parents disagreed with the study if the participant is equal or under 19 years old. (3) whose age is equal or over 25 years old. (4) Those who had taken a sleep clinic on sleep disorder before the intervention. (5) Those whose absenteeism had greatly affected by severe diseases, injury, and/or death of themselves or their relatives during the period of the study.
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Akiyoshi Middle name Last name Shimura
Organization	Tokyo medical university
Division name	Psychiatry
Zip code	160-0023
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3342-6111
Email	sim@tokyo-med.ac.jp

Public contact
1st name of contact person	1st name Akiyoshi Middle name Last name Shimura
Organization	Tokyo medical university
Division name	Psychiatry
Zip code	160-0023
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3342-6111
Homepage URL
Email	sim@tokyo-med.ac.jp

Sponsor
Institute	Tokyo medical university
Institute
Department

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	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical University Institutional Review Board
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel	03-3342-6111
Email	IRB@tokyo-med.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 10 Month 25 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	2017 Year 10 Month 25 Day
Date of IRB	2017 Year 08 Month 29 Day
Anticipated trial start date	2017 Year 10 Month 25 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 05 Month 31 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2019 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032312