UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on change in cerebral blood flow in frontal cortex after night shift using portable Near-infrared spectroscopy
Title of the study (Brief title)	Study on change in cerebral blood flow after night shift using portable Near-infrared spectroscopy
Region	Japan

Condition
Condition	Healthy Volunteer
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate change in cerebral blood flow after night shift in healthy volunteer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference between changes of cerebral blood flow in morning after night and day shift.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Portable near-infrared spectroscopy
Interventions/Control_2	Portable near-infrared spectroscopy
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	25 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Medical intern
Key exclusion criteria	1. Psychiatric disorder or physical disease 2. Medication or alcohol intake on study day 3. Night shift during several days
Target sample size	30

Research contact person
Name of lead principal investigator	Motohiro Ozone
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Address	3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL	+81-3-3433-1111
Email	ozone@jikei.ac.jp

Public contact
Name of contact person	Motohiro Ozone
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Address	3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL	+81-3-3433-1111
Homepage URL
Email	ozone@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Brain Energy Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 27 Day
Last modified on	2017 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027847