UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028466 |
|---|---|
| Receipt number | 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 | 2019/08/01 15:37:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Kenichi |
| Middle name | |
| Last name | Iwasaki |
Organization
Nihon University
Division name
School of Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
0339728111
iwasaki.kenichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Konishi |
Organization
Nihon University
Division name
School of Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
0339728111
Homepage URL
meto17002@g.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
Nihon University School of Medicine
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
Tel
0339728111
med.kenjim@nihon-u.ac.jp
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
https://www.physiology.org/doi/full/10.1152/japplphysiol.00119.2019
Publication of results
Published
Result
URL related to results and publications
https://www.physiology.org/doi/full/10.1152/japplphysiol.00119.2019
Number of participants that the trial has enrolled
17
Results
15 of 17 male participants completed 21 min of +1.5 Gz generated by short-arm centrifuge. Regional cerebral oxygen saturation by near-infrared spectroscopy (C-rSO2) and cerebral blood flow velocity by transcranial Doppler (CBFVMCA) were compared with pre-hypergravity (+1.0 Gz). C-rSO2 did not change significantly, although CBFVMCA significantly decreased. Contrary to our hypothesis, decreases in C-rSO2 were not detected, despite reductions in CBF velocity during hypergravity.
Results date posted
| 2019 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 06 | Month | 06 | Day |
Baseline Characteristics
17 healthy male volunteers who had no prior experience with a human centrifuge, participated in the study (age 24y; height 172.6cm; weight 69.2kg). All participants were confirmed that CBF velocity signals in the middle cerebral artery (MCA) could be obtained by TCD.
Participant flow
recruited by posters
Adverse events
None
Outcome measures
Regional cerebral oxygen saturation as measured by near-infrared spectroscopy (C-rSO2) and cerebral blood flow(CBF) velocity by transcranial Doppler ultrasonography in the middle cerebral artery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 04 | Day |
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
| 2019 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.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 |
