UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054442 |
|---|---|
| Receipt number | R000062189 |
| Scientific Title | Evaluation of Relaxation Effect by Periocular Thermal Stimulation |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/11/20 09:04:18 |
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Basic information
Public title
Evaluation of Relaxation Effect by Eye Mask
Acronym
Evaluation of Relaxation Effect by Eye Mask
Scientific Title
Evaluation of Relaxation Effect by Periocular Thermal Stimulation
Scientific Title:Acronym
Evaluation of Relaxation Effect by Thermal Stimulation
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relaxing effect of wearing an eye mask
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of alpha and theta waves when wearing an eye mask
Key secondary outcomes
-autonomic nervous system activity
-skin temperature change
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wear the test product eye mask >Washout for more than 1week >Wear a comparative eye mask >Washout for more than 1 week >Wear a control eye mask
(Eye mask wearing time is 30 minutes)
Interventions/Control_2
Wear a comparative eye mask >Washout for more than 1week >Wear the test product eye mask >Washout for more than 1week > Wear a control eye mask
(Eye mask wearing time is 30 minutes)
Interventions/Control_3
Wear a control eye mask >Washout for more than 1week >Wear a comparative eye mask >Washout for more than 1week > Wear the test product eye mask
(Eye mask wearing time is 30 minutes)
Interventions/Control_4
Wear the test product eye mask >Washout for more than 1week >Wear a control eye mask >Washout for more than 1 week >Wear a comparative eye mask
(Eye mask wearing time is 30 minutes)
Interventions/Control_5
Wear a comparative eye mask >Washout for more than 1week >Wear a control eye mask >Washout for more than 1week >Wear the test product eye mask
(Eye mask wearing time is 30 minutes)
Interventions/Control_6
Wear a control eye mask >Washout for more than 1week >Wear the test product eye mask >Washout for more than 1week >Wear a comparative eye mask
(Eye mask wearing time is 30 minutes)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy female aged 20-59
2. Person who has experience with eye masks
Key exclusion criteria
1.Person who has some problems due to eye mask use
2.Person who sleep less than 5 hours on average
3.Person who are sensitive to alcohol wipes or sticker application
4.Person who plan to participate in other studies
5.Person who deemed inappropriate by the principal investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Tagami |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
tagami.kyouko@kao.com
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Ishikawa |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
Homepage URL
ishikawa.aoi@kao.com
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2024 | Year | 05 | Month | 31 | 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
25
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
| 2024 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062189
