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 2022/06/16 09:47:19

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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

Email

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


Email

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

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



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

No longer recruiting

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

2022 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046538


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name