UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040757 |
|---|---|
| Receipt number | R000046538 |
| Scientific Title | Time course of changes in cerebral circulation during 30-degree head-down tilt |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2024/06/17 09:15:04 |
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Basic information
Public title
Time course of changes in cerebral circulation during 30-degree head-down tilt
Acronym
Time course of changes in cerebral circulation during 30-degree head-down tilt
Scientific Title
Time course of changes in cerebral circulation during 30-degree head-down tilt
Scientific Title:Acronym
Time course of changes in cerebral circulation during 30-degree head-down tilt
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate time course of changes in cerebral circulation during 30-degree head-down tilt
Basic objectives2
Others
Basic objectives -Others
Physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of changes in arterial blood pressure and cerebral blood flow velocity during 30-degree head down tilt
Key secondary outcomes
Intracranial pressure, pulsatility index, dynamic cerebral autoregulation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Head down tilt (-30 degrees) for 10 min
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults consented to participate in the study.
Key exclusion criteria
Not satisfy selection criteria noted above.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kato |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
TEL
03-3972-8111
kato.tomokazu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kato |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
TEL
03-2972-8111
Homepage URL
kato.tomokazu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
03-3972-8111
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 15 | 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
10
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
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046538
