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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028250
Receipt No. R000032329
Scientific Title Effects of compression stocking for shift worker during simulated night-work
Date of disclosure of the study information 2017/08/01
Last modified on 2018/07/20

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Basic information
Public title Effects of compression stocking for shift worker during simulated night-work
Acronym Effects of compression stocking for shift worker during simulated night-work
Scientific Title Effects of compression stocking for shift worker during simulated night-work
Scientific Title:Acronym Effects of compression stocking for shift worker during simulated night-work
Region
Japan

Condition
Condition healthy man
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Physiologcal effects of compresson stocking
Basic objectives2 Others
Basic objectives -Others sleepingness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HRV during simulated night-work
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 compression stocking during simlated night-work
Interventions/Control_2 without compression stocking during simlated night-work
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
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key inclusion criteria health by CMI
Key exclusion criteria extremy morningness type and eveningness type
psqi>5.5
shift worker
BMI>30
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomoko Wakamura
Organization Kyoto university
Division name graduate school of medicine
Zip code
Address 53 Shogoin kawhara-cho, Sakyo-ku, Kyoto
TEL 075-751-3974
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomoko Wakamura
Organization Kyoto university
Division name graduate school of medicine
Zip code
Address 53 Shogoin kawhara-cho, Sakyo-ku, Kyoto
TEL 075-751-3974
Homepage URL
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Sponsor
Institute Kaken
Institute
Department

Funding Source
Organization Kaken
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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 07 Month 15 Day
Last modified on
2018 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032329

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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