UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the effect of essential oil scent on cognitive function in a simulated bathroom environment
Acronym	Effects of essential oils on cognitive function
Scientific Title	Analysis of effects of essential oil exposure on cognitive function in simulated bathing environment
Scientific Title:Acronym	Effects of essential oil exposure on cognitive function
Region	Japan

Condition
Condition	Healthy young adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using essential oils (1,8-cineole) with known efficacy, observing the effect of differences in the method of exposure to fragrance on concentration transition, volatilizing exposure like general aromatherapy, Compare performance related to cognitive function with exposure in the form of bath additives.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Paced Auditory Serial Addition test(Immediately after exposure to essential oil)
Key secondary outcomes	Miyake Memory test, 1 minute word recall task

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Resting position(Only 20 minutes at a time)
Interventions/Control_2	Put only the head in the enclosed space(Only 20 minutes at a time)
Interventions/Control_3	Place only essential oil in the enclosed space(Only 20 minutes at a time, 1 ppm of 1,8-cineole)
Interventions/Control_4	Drop essential oil in a hot water container and stir with a water pump(Only 20 minutes at a time, 1 ppm of 1,8-cineole)
Interventions/Control_5	Stir the container with hot water with a water pump(Only 20 minutes at a time, 1 ppm of 1,8-cineole)
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	22 years-old >=
Gender	Male and Female
Key inclusion criteria	Adults with no abnormal olfaction
Key exclusion criteria	History of sinusitis or chronic illness
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Jun-ichi Middle name Last name Iiyama
Organization	Kumamoto Health Science University
Division name	Department of Health Science
Zip code	861-5598
Address	325 Izumi-machi, Kita-ku, Kumamoto, Japan
TEL	096-275-2111
Email	iiyama@kumamoto-hsu.ac.jp

Public contact
Name of contact person	1st name Jun-ichi Middle name Last name Iiyama
Organization	Kumamoto Health Science University
Division name	Department of Health Science
Zip code	861-5598
Address	325 Izumi-machi, Kita-ku, Kumamoto, Japan
TEL	096-275-2111
Homepage URL
Email	iiyama@kumamoto-hsu.ac.jp

Sponsor
Institute	Kumamoto Health Science University
Institute
Department

Funding Source
Organization	BATHCLIN CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Not applicable
Address	Not applicable
Tel	096-275-2111
Email	iiyama@kumamoto-hsu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 10 Month 09 Day
Date of IRB	2019 Year 10 Month 23 Day
Anticipated trial start date	2019 Year 12 Month 03 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 03 Day
Last modified on	2020 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044204