N/A(healthy adults)
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females aged 20-64 years. 2. Subjects who work from Monday to Friday and have Saturday and Sunday off 3. Subjects whose PSQI score at screening is over 6 points 4. Subjects who answer "before 24 o'clock" in Question 1 of the PSQI and "4 hours or more" in Question 4 at screening
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment due to chronic disease 2. Subjects with drug or food allergies 3. Subjects who are pregnant, lactating, or intending to be pregnant 4. Subjects who have more than 60 g/day of alcohol per week 5. Subjects who have or have a history of sleep apnea syndrome (SAS) 6. Subjects who have or have a history of serious hepatic disorder, renal disorder, cardiac disorder, pulmonary disorder, gastrointestinal disorder, diabetes, etc 7. Subjects with severe rhinitis 8. Subjects who have participated in other clinical trials during the month before screening, or are willing to participate in the other clinical trials during this study 9. Subjecsts who are day and night shift workers or physical labors 10. Subjects who score 10 or more on QIDS-J 11. Subjects who take at least 3 days per week of drugs or health foods that may affect this study 12. Subjects who live with infants or caregivers and sleep in an environment that prevents them from sleeping regardless of their own will 13. Subjects who cannot use smartphones to transmit and manage data from wearable devices, or who cannot download and operate apps 14. Subjects who cannot wear or operate wearable devices 15. Subjects who have a habit of taking a nap for more than an hour on weekdays 16. Subjects judged inappropriate for this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep questionnaire (OSA sleep inventory MA version, Pittsburgh Sleep Quality Index (PSQI)), VAS for stress and fatigue, total sleep time | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2nd Edition, blood cortisol, blood DHEA-S, salivary cortisol, salivary chromogranin A, salivary SIgA concentration, salivary SIgA secretory rate, sleep and heart rate data measured by activity tracker | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed