A verification test of the sleep improving effect of test equipment use
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000036144
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Subjects who have previous and/or current medical history of sleep impairment, or subjects who are being treated because of sleep impairment now. 2) Subjects who have been diagnosed as sleep apnea syndrome, or subjects who have noticed as apnea by themselves. 3) Subjects who have diagnosed as chronic low back pain, cervical spondylosis and/or osteoporosis in past, those disease are concerned about influence to using test device including stretch function. Or subjects who are being treated for the disease above. 4) Subjects who know that they easily to be influenced their sleep by environment change, such as using other bedding. 5) Subjects who don't be able to use sleep scope (single-channel EEG) during test period. 6) Subjects who have a planning of business trip or travel with lodging even once. 7) Subjects who don't be able to quit drink alcohol during test period. 8) Subjects who excessive alcohol intake. 9) Subjects who regularly use medicines, functional foods, foods for specified health use and/or supplements those concerned about influence for sleep. 10) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 12) Subjects who have severe menstrual pain or are diagnosed premenstrual syndrome (PMS). 13) Subjects who get a skin rash by attaching adhesive tape, because sensitive skin. 14) Subjects who use pacemaker. 15) Subjects who easily to get motion sickness. 16) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 17) Others who have been determined ineligible by principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method *The sleep score (evaluated by single-channel EEG) *OSA questionnaire *Japanese version of the Epworth Sleepiness Scale
- Secondary Outcome Measures
Name Time Method *The sleep diary *The incidence of side effects and/or adverse events.