None listed
Conditions
Interventions
Sleeping with the functions of test equipment on every day, for a week. Resting for one week. Sleeping without the functions of the test equipment on every day, for a week.
Sleeping without the functi
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female aged 30 to 64 when consent acquisition. 2) Subjects who have their body length 150cm to 185cm. 3) Subjects who answered that they don't satisfy their sleeping in questionnaire at preliminary test. 4) Subjects who are able to change their bedding to certain air-stretch mattress. 5) Subjects who are able to store their usual bedding during test period 6) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *The sleep score (evaluated by single-channel EEG) *OSA questionnaire *Japanese version of the Epworth Sleepiness Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| *The sleep diary *The incidence of side effects and/or adverse events. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed