UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029711 |
|---|---|
| Receipt number | 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 01:12:17 |
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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
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
sim@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032312
| Research Plan | |
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| 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 |
