None listed
Conditions
Interventions
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy Japanese male/female who are 20 years of age or older at the time of consent. (2)Subjects who are not satisfied with their sleep quality. (3)Those who are able to keep their bed room at their comfortable temperature. (4)Those 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)Those who are on treatment for a serious illness. (2)Those who are at late night work, shift work, or heavy work. (3)Those whose sleep time or sleep habits are irregular on weekdays. (4)Those who visit the hospital because of mental disorders (depression etc.) or sleep disorders, or who have been diagnosed with mental disorders. (5)Those who have been diagnosed as Sleep Apnea Syndrome or have subjective symptoms of apnea. (6)Those 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. (7)Those who are habitual smokers. (8)Those who are in the habit of consuming foods that inhibit sleepiness before bedtime or using devices that inhibit sleepiness. (9)Those who with metal Allergies or sensitive skin. (10)Those who may be prevented from sleep by others, including preschoolers, care required, one(s) who share bedroom. (11)Those with food allergies or those who may be allergic to the test food. (12)Those who regularly use licensed drugs or quasi-drugs that may affect the study. (13)Those who regularly use health foods that may affect the study. (14)Those who are participating in a clinical trial or have participated in another clinical trial within 1 months from the date of obtaining consent. (15)Those who may be unable to maintain their daily lifestyle. (16)Those who are pregnant or breastfeeding or planning to become pregnant during the study. (17)Those who plan to participate in any other clinical trial during the study. (18)Those who are deemed inappropriate for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version (OSA-MA), Visual analogue scale for sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA-MA (initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length), AIS, JESS, Electroencephalogram (initiation of sleep, nocturnal awakening, sleep efficiency, REM/non-REM sleep), Fitbit Versa 3 ( snore, noise level, sleep score), The proportion of division and family of intestinal bacteria | — |
Countries
Japan
Contacts
Public ContactYuki Kitahara
Apoplis Station Co.,Ltd. CRO Department Clinical Operations Division
Outcome results
None listed