臨床研究等提出・公開システム

Scientific Title	Effects of localized high temperature and humidity on the craniofacial region on olfactory stimulation (high temperature and humidity on olfactory function)
Public Title	Effects of localized high temperature and humidity on the craniofacial region on olfactory stimulation (high temperature and humidity on olfactory function)

Contact for Scientific Queries	Name	Iiyama Junichi
	Affiliation	Kumamoto Health Science University
	Address	Izumi 325, North ward, Kumamoto city, Kumamoto prefecture
	Telephone	+81-962752148
	E-mail	iiyama@kumamoto-hsu.ac.jp
Contact for Public Queries	Name	Iiyama Junichi
	Affiliation	Kumamoto Health Science University
	Address	Izumi 325, North ward, Kumamoto city, Kumamoto prefecture
	Telephone	+81-962752148
	E-mail	iiyama@kumamoto-hsu.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 19, 2023
Target sample size		30
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	single blind
	control	active control
	assignment	crossover assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	healthy young adults
	Exclusion Criteria	People who notice a loss of sense of smell after chronic sinusitis or upper respiratory tract infection
	Age Minimum	18age old over
	Age Maximum	23age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		olfactory disfunction
Intervention(s)		1,8-cineole or fragrance (composition cannot be disclosed as it is confidential company information)
Health Condition(s) Keyword		olfactory disfunction
Intervention(s) Keyword		1,8-cineole, olfactoly rehabiritation
Health Condition(s) Code		[C10. 292. 650]
Intervention(s) Code		[G16.500.275.640]
Primary Outcome(s)		Evaluation items include measurement of electroencephalogram and event-related potential P-300 as neurophysiological tests. In addition, a short version of the Profile of Mood States 2nd Edition for Adults will be administered as a neuropsychological test.
Secondary Outcome(s)		Blood pressure, pulse, and earlobe blood flow are measured as autonomic nerve tests.

Primary Sponsor	BATHCLIN CORPORATION

Source of Monetary Support / Secondary Sponsor	BATHCLIN CORPORATION
Secondary Sponsor	Applicable

Secondary Sponsor

Name of Certified Review Board	Kumamoto Health Science University Life Science Ethics Review Committee
Address	Izumi325, North ward, Kumamoto City, Kumamoto
Telephone	+81-962752148
E-Mail	kikaku@kumamoto-hsu.ac.jp
Approval Status	Approval
Date of approval	Aug. 24, 2023

Countries of Recruitment（Except Japan）	none