UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028250
Receipt number 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 15:17:48

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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

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

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 or person

Institute

Kaken

Institute

Department

Personal name



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

Value
https://center6.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