UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031325
Receipt number R000035756
Scientific Title The study to evaluate the effect of indoor environment on human motions and reactions.
Date of disclosure of the study information 2018/06/01
Last modified on 2018/03/26 17:28:54

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Basic information

Public title

The study to evaluate the effect of indoor environment on human motions and reactions.

Acronym

The study to evaluate the effect of indoor environment on human motions and reactions.

Scientific Title

The study to evaluate the effect of indoor environment on human motions and reactions.

Scientific Title:Acronym

The study to evaluate the effect of indoor environment on human motions and reactions.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate some kinds of effects of indoor environment on human.

Basic objectives2

Others

Basic objectives -Others

Research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

heart rate,pulse wave,nose temperature
Questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-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

Strength of air conditioning
Brightness of lighting

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.20 years of age or older.
2.Male and female.
3.Those who sleep in 6 hours or more in the trial period as usual.
4.Non smoker.
5.Owner of the smartphone.
6.Those who are able to participate in all of the exam.
7.Those who are able to sign an informed consent.

Key exclusion criteria

1.Those who are undergoing treatment.
2.Those who considered to have poor judgment ability(dementia,mental illness,etc.)
3.Those whom the Principal Investigator judged as inappropriate for participating in the trial.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyoshi Harimoto

Organization

TAISEI Corporation

Division name

Energy Research Section,Urban Engineering Research Department,Technology Center

Zip code


Address

344-1,Nase-cho,Totsuka-ku,Yokohama,Japan

TEL

090-9026-7660

Email

kazuyoshi.harimoto@sakura.taisei.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuyoshi Harimoto

Organization

TAISEI Corporation

Division name

Energy Research Section,Urban Engineering Research Department,Technology Center

Zip code


Address

344-1,Nase-cho,Totsuka-ku,Yokohama,Japan

TEL

090-9026-7660

Homepage URL


Email

kazuyoshi.harimoto@sakura.taisei.co.jp


Sponsor or person

Institute

TAISEI CORPORATION
KANEKA CORPORATION

Institute

Department

Personal name



Funding Source

Organization

TAISEI CORPORATION
KANEKA CORPORATION

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 06 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

2018 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 19 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

2018 Year 02 Month 15 Day

Last modified on

2018 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name