UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049356 |
|---|---|
| Receipt number | R000056207 |
| Scientific Title | Verification of sleep effect by applying a steam eye mask before bedtime |
| Date of disclosure of the study information | 2022/11/10 |
| Last modified on | 2023/08/26 22:00:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of sleep effect by applying a steam eye mask before bedtime
Acronym
Verification of sleep effect by applying a steam eye mask
Scientific Title
Verification of sleep effect by applying a steam eye mask before bedtime
Scientific Title:Acronym
Verification of sleep effect by applying a steam eye mask
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the sleep status and the profile of mood state by applying a steam eye mask.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of subjective sleep score and the mood states.
Key secondary outcomes
-Objective sleep index from Fitbit
-Profile of Mood States (POMS)
-Trait Anxiety Inventory (STAI)
-Psychological Well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1.Observation period for 1 week.
2.Applying a steam eye mask at bedtime once a day for 4 weeks.
Interventions/Control_2
1.Observation period for 1 week.
2.Applying a sham eye mask at bedtime once a day for 4 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Female with sleep difficulty
2.Female aged 20-49
3.Person who agrees to use the wearable device Fitbit.
Key exclusion criteria
1.Subjects having no experience using a steam eye mask
2.Subjects having psychiatric disorders other than sleep disorder
3.Subjects having sleep disorders other than insomnia disorders (hypersomnolence disorder, breathing- related sleep disorders, parasomnias. etc.)
4.Subjects having caused the body trouble by periocular warming in the past
5.Subjects having following diseases; cardiovascular disease, a neuropsychiatric disorder (alcohol/drug dependence or abuse)
6.shift worker.
7.Subjects having changed their medications such as sleeping pills during the study period
8.Subjects having disorders (pain, pruritus, fever, diarrhea, frequent urination, etc.) obstruct sleep quality.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Hideshi |
| Middle name | |
| Last name | Oda |
Organization
Kao Corporation
Division name
Personal Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
oda.hideshi@kao.com
Public contact
Name of contact person
| 1st name | Hotaka |
| Middle name | |
| Last name | Takakuwa |
Organization
Kao Corporation
Division name
Personal Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
Homepage URL
takakuwa.hotaka@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
| 2022 | Year | 11 | Month | 10 | 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
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
| 2022 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
