Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: Electric potential therapy instrument TSUBAKI 14000 Administration: Use daily between dinner and bedtime, seated in a chair or on the floor for 60 minutes. *If
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. Men or women 3. Individuals aged 40 or more 4. Healthy individuals 5. Individuals who are concerned about their sleep quality 6. Individuals who have low Zc score of "initiation and maintenance of sleep" in the OSA-MA at screening (before intervention)
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking or using medications (including herbal medicines) and supplements 6. are allergic to medicines and foods related to the test product 7. live with infants less than one year old 8. sleep with children (1 to 6 years old) 9. live with requiring long-term care persons 10. sleep with more than one person 11. have irregular sleeping time or habit due to work such as a late-night shift 12. have nocturia three times or more 13. are restricted from daily intense physical activity due to diseases or other reasons 14. are using a wearable medical electrical equipment, such as an electrocardiograph 15. need to rest 16. have temperature sensory loss 17. have sleep apnea syndrome 18. are taking antithrombotic drugs or undergoing medical treatment for hematogenous disorders 19. may be jumped on or suddenly touched by persons, objects, or pets while using the test product 20. cannot use the test product with a proper understanding of its use and precautions 21. are pregnant, lactating, or planning to become pregnant during this study 22. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 23. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item in the OSA sleep inventory MA version (OSA-MA) at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individuals whose answers to original questionnaire ("My whole body is cold," "My fingers and toes are cold," "My body temperature is not stable," "My body feels heavy," "I feel irritated," "I feel malaise," "I have lower back pain and shoulder stiffness," "I have trouble falling asleep," "My sleep is light," and "I wake up in my sleep") are improved by one or more levels at 4w 2. The measured values of sleep scan (measurement time, sleep score, total bedtime, sleep onset latency, total sleep time, actual sleep time, sleep efficiency, wake time after sleep onset, number of waking up, the time of microarousal, number of microarousal, rapid eye movements (REM) sleep latency, latency to deep sleep, amount of arousal appearance, rate of arousal appearance, amount of REM appearance, rate of REM appearance, amount of light sleep appearance, rate of light sleep appearance, amount of deep sleep appearance, rate of deep sleep, number of sleep-stage transition, number of arousal-stage appearance, number of REM sleep-stage appearance, number of light sleep-stage appearance, number of deep sleep-stage appearance, rate of deep sleep (the first half), rate of deep sleep (the latter half), mean pulse rate, maximal pulse rate, minimal pulse rate, sleep cycle, number of body motion detection, sleep depth score, sleep cycle score, sleep time score, wake after sleep onset score) at 4w 3. The measured value of body temperature at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed