UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024190 |
|---|---|
| Receipt number | R000027847 |
| Scientific Title | Study on change in cerebral blood flow in frontal cortex after night shift using portable Near-infrared spectroscopy |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2017/06/07 12:25:58 |
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Basic information
Public title
Study on change in cerebral blood flow in frontal cortex after night shift using portable Near-infrared spectroscopy
Acronym
Study on change in cerebral blood flow after night shift using portable Near-infrared spectroscopy
Scientific Title
Study on change in cerebral blood flow in frontal cortex after night shift using portable Near-infrared spectroscopy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Motohiro Ozone |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL
+81-3-3433-1111
ozone@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Ozone |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL
+81-3-3433-1111
Homepage URL
ozone@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027847
