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.Those who are not satisfied with their sleep quality. 3.Those who can set the room temperature in his/her bedroom at a temperature suitable for sleeping. 4.Those who have regular and stable menstrual cycle (Those who can avoid the period to get the sleep test). 5.Those who have signed a consent 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 students. 2.Those who are on treatment for a serious illness. 3.Those who are at late night work, shift work, or heavy work. 4.Those whose sleep time or sleep habits are irregular on weekdays. 5.Those who visit the hospital because of mental disorders(depression etc.) or sleep disorders, or who have been diagnosed with mental disorders. 6.Those who have been diagnosed as Sleep Apnea Syndrome or have subjective symptoms of apnea. 7.Those who have symptoms of nocturia. Or, those who are on medication for urinary disease. 8.Those who select"I would like to kill myself." or "I would kill myself if I had the chance."at question 9 of BDI2 at the screening test. 9.Those who are habitual smokers. 10.Those who consume excessive alcohol or caffeine(e.g., have been diagnosed with alcoholism or caffeine addiction) 11.Those who do not habitually drink caffein contained beverages such as green tea and coffee. 12.Those who are in the habit of consuming foods that inhibit sleepiness before bedtime or using devices that inhibit sleepiness. 13.Those with metal allergy (skin problems due to electrodes), persons with weak skin. 14.Those who may be prevented from sleep by others. 15.Those with food allergies. 16.Those who regularly use licensed drugs or quasi-drugs that may affect the study. 17.Those who regularly use health foods that may affect the study. 18.Those who are participating in a clinical trial or have participated in another clinical trial within 1 months before the date of consent for this study. 19.Those who are unable to maintain their daily routine during the study. 20.Those whose sleep pattern may change during the study due to travel abroad or business trips. 21.Those who plan to participate in any other clinical trial during the study. 22.Those who have severe symptoms of PMS or menopausal disorders. 23.Those who plan to participate in any other clinical trial during the study. 24.Those who are deemed inappropriate for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep EEG (Telemetric electroencephalograph InSomnograph M2) | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA-MA (drowsiness upon awakening ,initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length), PSQI, JESS | — |
Countries
Japan
Contacts
Public ContactMasako Mizuuchi
APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division
Outcome results
None listed