UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of compression stocking for shift worker during simulated night-work
Title of the study (Brief title)	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
Name of lead principal investigator	Tomoko Wakamura
Organization	Kyoto university
Division name	graduate school of medicine
Address	53 Shogoin kawhara-cho, Sakyo-ku, Kyoto
TEL	075-751-3974
Email	wakamura.tomoko.5v@kyoto-u.ac.jp

Public contact
Name of contact person	Tomoko Wakamura
Organization	Kyoto university
Division name	graduate school of medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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