UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061051 |
|---|---|
| Receipt number | R000069857 |
| Scientific Title | An Investigation into the Effects of Changes in Sleep Quality on Next-Day Brain Function |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/25 15:09:08 |
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Basic information
Public title
A Study on How Sleep Quality Affects Brain Function the Following Day
Acronym
Sleep and Next-Day Brain Function Study
Scientific Title
An Investigation into the Effects of Changes in Sleep Quality on Next-Day Brain Function
Scientific Title:Acronym
Sleep Quality-Brain Function Study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine how changes in sleep quality affect resting-state functional connectivity the following day.
Basic objectives2
Others
Basic objectives -Others
To validate the reproducibility of our previous findings suggesting that sleep quality influences next-day resting-state functional connectivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations among sleep-quality indicators under caffeine and placebo conditions (such as total sleep time, wake after sleep onset, and sleep spindle duration), brain functional connectivity derived from resting-state fMRI and task-based fMRI during attention and memory tasks, cognitive task performance, and psychological assessment scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Group A: Pharmaceutical X -> (washout period) -> Food Y
Interventions/Control_2
Group B: Food Y -> (washout period) -> Pharmaceutical X
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. Individuals who have the capacity to provide written informed consent for participation in this study.
2. Male participants aged 18 years or older and under 40 years at the time of consent.
3. Individuals whose habitual caffeine intake is below the recommended amount for healthy adults (<400 mg/day).
4. Individuals who have no abnormalities in sleep or general health status.
5. Individuals who, within the 3 months prior to obtaining consent, have not habitually used tobacco that could affect sleep, have not received any sleep related medical treatment, and have not engaged in shift work or experienced travel across time zones.
6. Individuals judged by a physician (investigator or sub investigator) to have no health problems.
Key exclusion criteria
1. Individuals with a history of serious physical illness or brain disorders in the past or present.
2. Individuals with drug dependence or alcohol dependence.
3. Individuals who are ineligible for MRI examinations(e.g., those with magnetic metal in the body such as tattoos or intraocular lenses, or those with claustrophobia or fear of darkness).
4. Individuals for whom caffeine intake is contraindicated. As a criterion, the description in the package insert of caffeine tablets-such as those regarding heart disease or excessive gastric acid secretion-must be followed.
5. Any other individuals deemed inappropriate as research participants by the physician who is also a researcher.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Tachibana |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute for Quantum Medical Science Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-382-4304
tachibana.yasuhiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | Sahara |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute for Quantum Medical Science Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-382-4304
Homepage URL
sahara.yasuka@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum 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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069857
