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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029711
Receipt No. R000032312
Scientific Title The efficacy of the tailored sleep hygiene intervention on the sleep disturbance, absenteeism, and presenteeism among adolescent: A randomized controlled study.
Date of disclosure of the study information 2017/10/25
Last modified on 2019/04/25

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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
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
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

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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