UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029877 |
|---|---|
| Receipt number | 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 14:00:48 |
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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
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
Nakamura.yuka2@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034128
