UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017380
Receipt number R000020169
Scientific Title Effects on the brain function by which the difference in the bathing environment
Date of disclosure of the study information 2015/05/01
Last modified on 2015/05/01 18:24:32

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Basic information

Public title

Effects on the brain function by which the difference in the bathing environment

Acronym

Effects on the brain function by which the difference in the bathing environment

Scientific Title

Effects on the brain function by which the difference in the bathing environment

Scientific Title:Acronym

Effects on the brain function by which the difference in the bathing environment

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the comfort

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The results indicate activity of the frontal lobe decline with low lighting and wide bathtub.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

This study was to investigate effects of lighting intensity of bathroom and bathtub size on activity of the frontal cortex and autonomic nervous system of the healthy subjects.

Interventions/Control_2


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

24 years-old <=

Age-upper limit

41 years-old >=

Gender

Male

Key inclusion criteria

healthy volunteer

Key exclusion criteria

free of neurological or medical illnesses

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuta Kawashima

Organization

Tohoku University

Division name

Institute of Development, Aging and Cancer

Zip code


Address

Seiryo-machi 4-1, Aoba-ku, Sendai

TEL

022-717-7988

Email

ryuta.kawashima.a6@tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akitake Kanno

Organization

Tohoku University

Division name

Institute of Development, Aging and Cancer

Zip code


Address

Seiryo-machi 4-1, Aoba-ku, Sendai

TEL

022-717-7988

Homepage URL


Email

akik@idac.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

TOTO LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

2015 Year 05 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

Completed

Date of protocol fixation

2014 Year 06 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 05 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

2015 Year 05 Month 01 Day

Last modified on

2015 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name