Healthy Japanese subjects
Conditions
Interventions
Duration: One week Intervention: Sleep for five hours in daily for seven days
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who usually sleep for approximately eight hours 6. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who live with their infants less than one year old 5. Subjects who co-sleep with their children (one to six years old) 6. Subjects whose sleeping time or habit is irregular due to working a late-night shift 7. Subjects who wake up for urination three times or more during nocturnal sleep 8. Subjects who have the opportunity to drive (passenger cars, motorcycles, buses, trains, airplanes, other vehicles that require a license, bicycles, and kick scooters) during the study 9. Subjects who may intensely exercise during the study 10. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 11. Subjects currently taking medicines (include herbal medicines) and supplements 12. Subjects who are allergic to medications 13. Subjects who are pregnant, breast-feeding, and planning to become pregnant 14. Subjects who suffer from COVID-19 15. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 16. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of metabolome analysis of salivary after sleep deprivation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of metabolome analysis of salivary from screening (before sleep deprivation; Scr) to after sleep deprivation 2. The measured values and amount of change from Scr in each items of sleep test (Sleep Scan) after sleep deprivation 3. The measured values and amount of change from Scr in each items of Pittsburgh Sleep Quality Index (PSQI ) after sleep deprivation | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed