NIPH Clinical Trials Search

A study to evaluate the effects of the shiki futon mattress on improving sleep quality

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy volunteers
Date of first enrollment	2021/04/27
Target sample size	18
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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

Outcome(s)

Primary Outcome	OSA sleep inventory MA version
Secondary Outcome	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)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	65years-old
Gender	Male and Female
Include 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
Exclude 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