Verification of efficacy of the test foods on sleep quality.
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000052248
- Lead Sponsor
- APO PLUS STATION CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep EEG (Telemetric electroencephalograph InSomnograph M2)
- Secondary Outcome Measures
Name Time Method OSA-MA (drowsiness upon awakening ,initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length), PSQI, JESS