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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028466
Receipt No. R000032588
Scientific Title Changes in cerebral regional oxygen saturation during 1.5Gz hypergravity exposure
Date of disclosure of the study information 2017/07/31
Last modified on 2018/07/25

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Basic information
Public title Changes in cerebral regional oxygen saturation during 1.5Gz hypergravity exposure
Acronym rSO2 during mild hypergravity
Scientific Title Changes in cerebral regional oxygen saturation during 1.5Gz hypergravity exposure
Scientific Title:Acronym rSO2 during mild hypergravity
Region
Japan

Condition
Condition NA
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to reveal the changes in cerebral regional oxygen saturation during 1.5Gz hypergravity exposure.
Basic objectives2 Others
Basic objectives -Others We will test the hypothesis that cerebral regional oxygen saturation decreases during 21-min exposure to 1.5Gz hypergravity.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cerebral regional oxygen saturation
Key secondary outcomes cerebral blood flow velocity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 hypergravity exposure(centrifuge), 1.5Gz, 21 minutes X once
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 healthy
Key exclusion criteria circulatory diseases
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Iwasaki
Organization Nihon University
Division name School of Medicine
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL 0339728111
Email iwasaki.kenichi@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Konishi
Organization Nihon University
Division name School of Medicine
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL 0339728111
Homepage URL
Email meto17002@g.nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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 日本大学医学部(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
2017 Year 12 Month 27 Day
Date of closure to data entry
2017 Year 12 Month 27 Day
Date trial data considered complete
2018 Year 01 Month 17 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032588

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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