Healthy volunteers
Conditions
Interventions
Sleep on the novel type shiki futon ->
Sleep on the conventional type shiki futon
Sleep on the conventional type shiki futon ->
Sleep on the novel type shiki futon
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females whose age of 20 years or more and less than 65 years 2. Subjects who are aware of impaired sleep quality 3. Subjects whose Pittsburgh Sleep Quality Index scores are 6 points or more 4. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects receiving a medical treatment for sleep disorders 2. Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3. Subjects who take pharmaceuticals or quasi-drugs which having the efficacy for improving sleep quality 4. Subjects who take Foods with Function Claims labeled the effect of improving sleep quality 5. Subjects whose lifestyles are irregular because of night shift or others 6. Subjects who wake up for urination 2 times or more during nocturnal sleep 7. Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 8. Subjects who take part in another clinical study 9. Female subjects who are pregnant or lactating, or intending to become pregnant during the study 10. Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version | — |
Secondary
| Measure | Time frame |
|---|---|
| The St. Mary's Hospital sleep questionnaire, VAS, POMS 2nd edition short version, Activity tracker (SAT-1), Autonomic nervous function evaluation (spectral analysis of heart beat using myBeat and a-a interval of accelerated plethysmography) | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed