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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029877
Receipt No. R000034128
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
Date of disclosure of the study information 2017/11/21
Last modified on 2019/05/10

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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