UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052114 |
|---|---|
| Receipt number | R000059349 |
| Scientific Title | Development of a new experimental protocol for measuring daytime performance based on detecting cerebral blood flow. |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2025/10/27 15:49:22 |
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Basic information
Public title
Development of a new experimental protocol for measuring daytime performance based on detecting cerebral blood flow.
Acronym
Development of a new experimental protocol for measuring daytime performance based on detecting cerebral blood flow.
Scientific Title
Development of a new experimental protocol for measuring daytime performance based on detecting cerebral blood flow.
Scientific Title:Acronym
Development of a new experimental protocol for measuring daytime performance based on detecting cerebral blood flow.
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To optimize an experimental protocol for measuring daytime performance based on detecting cerebral blood flow.
Basic objectives2
Others
Basic objectives -Others
To validate optimized experimental protocol for measuring daytime performance based on detecting cerebral blood flow.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Cerebral Blood Flow
Key secondary outcomes
Sleep Electroencephalogram (EEG)
Karolinska Sleepiness Scale
Mood questionnaire (VAS)
Oguri-Shirakawa-Azumi Sleep Inventory, Middle-age and aged version (OSA-MA)
Heart Rate Variability
Performance in Brain Stimulation Tasks (Accuracy, Reaction Time)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep restriction
Interventions/Control_2
Non intervention
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged between 30 and 50 at the time of consent, with a dominant right hand.
2. Subjects who work in office three or more times a week.
3. Subjects whose weekday bedtime falls between 10:30 PM and 12:30 AM and wake-up time falls between 5:30 AM and 7:30 AM.
4. Subjects who sleep for 6 to 8 hours per day on weekdays.
5. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects consuming foods claiming to improve stress, sleep, or fatigue more than once a week.
2. Shift workers or overnight workers.
3. Subjects engaged in heavy lifting or other physical work.
4. Subjects who excessive alcohol intake.
5. Smokers (except for those who have quit for more than six months).
6. Subjects participating in other clinical trials for drugs or health foods, or who plan to participate in other clinical trials during or within four weeks after this trial.
7. Subjects who experience significant discomfort in sleeping environments other than their home (difficulty falling asleep, etc.).
8. Subjects with injuries or other conditions that make fNIRS measurement difficult in the frontal lobe.
9. Subjects aware of color vision abnormalities.
10. Subjects who experience nocturnal polyuria (urinating more than twice per night).
11. Subjects with severe allergic rhinitis.
12. Subjects with a current medical history of reflux esophagitis.
13. Subjects on medication.
14. Subjects who have received or are currently receiving exercise or dietary therapy.
15. Subjects receiving medical treatment or counseling for stress, sleep, or fatigue.
16. Subjects diagnosed with overactive bladder.
17. Subjects with a past or current history of sleep disorders such as sleep apnea syndrome, or who suspect or are aware of such disorders.
18. Subjects with a past or current history of mental illness, chronic fatigue syndrome, brain injuries, cognitive disabilities, or learning disabilities.
19. Subjects with a past or current history of serious diseases involving the heart, liver, kidney, digestive system, metabolism, or endocrine system.
20. Subjects who are pregnant or lactating, and females who could become pregnant or lactating during test period.
21. Subjects using a pacemaker.
22. Subjects with skin diseases or sensitive skin at the sites where electrodes for EEG and heart rate monitors will be attached (forehead, under the ears, chest).
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2024 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
23. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059349
