Male/female adults
Conditions
Interventions
Sleep restriction
Non intervention
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Cerebral Blood Flow | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed