UMIN-CTR Clinical Trial

Basic information
Public title	A study examining the influence of fragrances using eye mask under warming therapies on daily emotion and self-reported sleep quality in subject who tends to lower the quality of sleep
Acronym	A study examining the influence of fragrances using eyemask under warming therapies on daily emotion and self-reported sleep quality
Scientific Title	A study examining the influence of fragrances using eye mask under warming therapies on daily emotion and self-reported sleep quality in subject who tends to lower the quality of sleep
Scientific Title:Acronym	A study examining the influence of fragrances using eyemask under warming therapies on daily emotion and self-reported sleep quality
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether fragrances under warming therapies using eye mask improve daily emotion and self-reported sleep quality on daily emotion and self-reported sleep quality
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The improvement of mood state using visual analog scale
Key secondary outcomes	Self-reported sleep quality Sleep quality examination with Actiwatch

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	No treatment (first day) ->Treatment A (three days/first week)->Treatment B (three days/second week) Treatment A: Appling a test product before sleeping Treatment B: Appling a placebo product before sleeping.
Interventions/Control_2	No treatment (first day) ->Treatment B(three days/first week)->Treatment A (three days/second week) Treatment A: Appling a test product before sleeping Treatment B: Appling a placebo product before sleeping
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key inclusion criteria	Healthy females With unsatisfactory state about the quality of daily sleep
Key exclusion criteria	1)Subjects who dislike perfumed products 2)Subjects who takes sleeping pills 3)Subjects who have chronic heart failure, chronic respiratory disease, renal failure and diabetes 4)Subjects who are pregnancy and suspected pregnancy
Target sample size	24

Research contact person
Last name of lead principal investigator	1st name Yoshihiro Middle name Last name Hasegawa
Organization	Kao Corporation
Division name	Perfumery Development Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku, Tokyo
TEL	+81-3-5630-9437
Email	Hasegawa.yoshihiro@kao.co.jp

Public contact
1st name of contact person	1st name Yuka Middle name Last name Nakamura
Organization	Kao Corporation
Division name	Perfumery Development Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku, Tokyo
TEL	+81-3-5630-9465
Homepage URL
Email	Nakamura.yuka2@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao 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	Kao corporation
Address	2-1-3 BUnka Sumida-ku
Tel	+81-3-5630-9220
Email	uesaka.toshio@kao.co.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	2017 Year 11 Month 21 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	21
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	2017 Year 10 Month 31 Day
Date of IRB	2017 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 11 Month 21 Day
Last follow-up date	2017 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2019 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034128