UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029270 |
|---|---|
| Receipt number | R000033458 |
| Scientific Title | Randomized control trial of individual brief sleep hygiene education for sleep and productivity in the workplace |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2017/09/25 05:16:26 |
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Basic information
Public title
Randomized control trial of individual brief sleep hygiene education for sleep and productivity in the workplace
Acronym
Intervention study of individual brief sleep hygiene education
Scientific Title
Randomized control trial of individual brief sleep hygiene education for sleep and productivity in the workplace
Scientific Title:Acronym
Intervention study of individual brief sleep hygiene education
Region
| Japan |
Condition
Condition
sleep
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effectiveness measurement for sleep hygiene education
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
Key secondary outcomes
work productivity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
individual brief sleep hygiene education
(30 minutes)
Interventions/Control_2
follow-up by e-mail for 6 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
more than 5 points of Pittsburgh Sleep Quality Index
Key exclusion criteria
suspect of sleep apnea syndrome
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health
Division name
Institute of Industrial Ecological Sciences
Zip code
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL
093-603-1611
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health
Division name
Institute of Industrial Ecological Sciences
Zip code
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL
093-603-1611
Homepage URL
tomohisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Institute of Industrial Ecological Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Address
Tel
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
産業医科大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033458
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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