Healthy adults
Conditions
Interventions
Duration: 4 weeks Test product: Cosmo. Dr 14000
Duration: 4 weeks Test product:none
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Males or postmenopausal women who are distressed by sleeplessness b) Persons who are over 40 years old
Exclusion criteria
Exclusion criteria: a) Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction b) Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease c) Persons who take medicines, herbal medicines, or other therapeutic devices to treat severe pollinosis or by other reasons d) Persons who are applied medical electronic equipment (self-contained device such as pacemakers, life-supporting equipment such as cardiopulmonary bypass, wearable devices such as electrocardiograph) e) Persons who live with infants less than 6 years old f) Persons whose sleep period or sleeping habits are irregular due to night works or other reasons g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons whose menstruation cycle is irregular i) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial j) Persons who are judged not suitable to participate in this trial by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep characteristics measured by SleepScan SL503 Sleep Score Ratio of deep sleep Number of nocturnal awakening Ratio of nocturnal awakening OSA sleep inventory MA version sleepiness on rising initiation and maintenance of sleep frequent dreaming refreshing sleep length | — |
Secondary
| Measure | Time frame |
|---|---|
| Likert scales body temperature measurement | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed