臨床研究等提出・公開システム

Scientific Title	Exploration of the effects of sleep on work engagement, cognitive function, and clinical data
Public Title	Exploration of sleep effects

Contact for Scientific Queries	Name	Nakao Mutsuhiro
	Affiliation	Showa University
	Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo , Japan
	Telephone	+81-3-3784-8917
	E-mail	stmanage@med.showa-u.ac.jp
Contact for Public Queries	Name	Tani Yasuo
	Affiliation	Kanagawa Prefectural Government
	Address	1 Nihon-odori, Naka-ku, Yokohama, Kanagawa, Japan
	Telephone	+81-45-285-0778
	E-mail	tani.4wea@aol.com

Recruitment status	Pending

Anticipated date of first enrollment		Aug. 19, 2024
Actual date of first enrollment
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	Employees and residents of elderly care facilities"Mazeran Shonansajima" who have given their consent
	Exclusion Criteria	Pregnant women, people with soy, chicken, or egg allergies
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		- Deep sleep percentage - Work Engagement - Self Efficacy - Cognitive function
Intervention(s)		- Have Apple Watch worn at all times - Have blood pressure, vascular flexibility, and cognitive function measured once a week. - Have four types of supplements for 30 days taken with a 7 day wash out period. *Efficacy and effects of supplements 1.L-Theanine 200mg/day : Reduced feeling of fatigue when waking up 2.ChronoCare 116mg/day : Adjustment of autonomic nervous function 3.Nemunos 200mg/day : Adjustment of circadian rhythm 4.Plasmalogen 1mg/day : Improved cognitive function
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- Deep sleep percentage - Work Engagement - Self Efficacy - Cognitive function
Secondary Outcome(s)		- Blood pressure - Flexibility of blood vessels

Primary Sponsor	SOYOKAZE Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Kanagawa Institute of Industrial Science and Technology
Secondary Sponsor	Not applicable

Name of Certified Review Board	NPO Community Health Plan
Address	2-7-23, Nanuka-Machi, Yamagata-city, Yamagata,, Yamagata
Telephone
E-Mail
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none