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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029270
Receipt No. 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

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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
Email 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
Email tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Institute of Industrial Ecological Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033458

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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