UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042749 |
|---|---|
| Receipt number | R000048770 |
| Scientific Title | Relationship between sleep quality and brain function connectivity obtained with fMRI |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2021/04/20 13:13:34 |
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Basic information
Public title
Relationship between sleep quality and brain function connectivity obtained with fMRI
Acronym
Relationship between sleep quality and fMRI
Scientific Title
Relationship between sleep quality and brain function connectivity obtained with fMRI
Scientific Title:Acronym
Relationship between sleep quality and fMRI
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the latest sleep quality affects brain function using fMRI on the following day.
Basic objectives2
Others
Basic objectives -Others
neurophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between sleep quality indicators obtained with Sleep Profiler and brain functional connectivity with fMRI.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
1. History of severe systematic / CNS disease.
2. Drug and/or alcoholic abuse.
3. Not adaptable for MRI scanning (e.g. metallic devices, claustrophobia, nyctophobia)
4.Women who are/may pregnant
5. Operator's decision as not suitable for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Obata |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Molecular Imaging and Theranostics
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3230
obata.takayuki@qst.go.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | Sahara |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Molecular Imaging and Theranostics
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3230
Homepage URL
sahara.yasuka@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture Sports, Science and Technology
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
National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
Tel
043-206-4706
helsinki@qst.go.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 | 12 | 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
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
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Relationship between sleep quality and fMRI
Randomized sample
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048770
