None listed
Conditions
Interventions
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese men and women who are 20 years of age or older at the time of consent. (2) Subjects who are concerned about their sleep quality. (3) Persons who have signed a consent form prior to the start of the study upon full explanation of the purpose and content of the study.
Exclusion criteria
Exclusion criteria: (1) Persons who are on treatment for a serious illness. (2) Persons whose sleep time or sleep habits are irregular because of night shift etc. (3) Persons who visit the hospital because of mental disorders (depression etc.) or sleep disorders, or were diagnosed with mental disorders at once. (4) Persons who are diagnosed Sleep Apnea Syndrome or have subjective symptoms of apnea. (5) Subjects who select "I would like to kill myself." or "I would kill myself if I had the chance." at question 9 of Beck Depression Inventory-II (BDI2) at the screening test. (6) Habitual Smokers. (7) Persons who have metal Allergy or sensitive skin. (8) Persons who may be prevented from sound sleep by the other, for instance, who have preschoolers, who nurse care, who sleep on the bed two or more. (9) Persons with food allergies or those who may be allergic to the test food. (10) Persons who regularly use licensed drugs or quasi-drugs that may affect the study. (11) Persons who regularly use health foods that may affect the study. (12) Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent. (13) Persons unable to maintain daily routines. (14) Pregnant, lactating, or wishing to become pregnant. (15) Persons who plan to participate in other examinations during the study. (16) Other subjects who are deemed inappropriate for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Check for "Sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) | — |
Secondary
| Measure | Time frame |
|---|---|
| "Initiation and maintenance of sleep" , "frequent dreaming", "refreshing", "sleep length" in the OSA-MA, PSQI, JESS, The sleep scope (Electroencephalogram (Initiation of sleep, Nocturnal awakening, Sleep efficiency), Sleep stage(REM/non-REM sleep)), The proportion of division or family of intestinal bacteria | — |
Countries
Japan
Contacts
Public ContactYoshimura Hiroki
Apoplus Station Co.,Ltd. CRO Department Clinical Operations Division
Outcome results
None listed