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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036541
Receipt No. R000041634
Scientific Title Dose-dependent effects of head down tilt on cerebral circulation
Date of disclosure of the study information 2019/04/18
Last modified on 2019/05/22

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Basic information
Public title Effects of head down tilt on cerebral circulation
Acronym Effects of head down tilt on cerebral circulation
Scientific Title Dose-dependent effects of head down tilt on cerebral circulation
Scientific Title:Acronym Dose-dependent effects of head down tilt on cerebral circulation
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to investigate dose-dependent effects of head down tilt on cerebral circulation.
Basic objectives2 Others
Basic objectives -Others Physiological changes
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Gain, coherence and phase between arterial blood pressure and cerebral blood flow variabilities in the spine position, and head down tilt position (-10, -30 degrees)
Key secondary outcomes Cerebral blood flow velocity, pulsatility index, blood pressure variability, respiratory indexes, intracranial pressure, baroreflex function, heart rate variability, skin blood flow

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Head-down tilt (-30 degrees) position for 10 min
Interventions/Control_2 Head-down tilt (-10 degrees) position for 10 min
Interventions/Control_3 Horizontal position, (0 degree) for 10 min
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
Cerebral blood flow velocity signals in the middle cerebral artery can be obtained by transcranial Doppler ultrasonography.
Key exclusion criteria Not satisfy selection criteria noted above
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name IWASAKI
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
Email iwasaki.kenichi@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 03-3972-8111
Homepage URL
Email kato.tomokazu@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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
Email 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

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 18 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 23 Day
Date of IRB
2017 Year 07 Month 31 Day
Anticipated trial start date
2019 Year 05 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 18 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041634

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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