UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062507 |
|---|---|
| Receipt number | R000071557 |
| Scientific Title | Sleep Assessment Study by Periorbital Cooling |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/07 13:44:57 |
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Basic information
Public title
Sleep Assessment Study by Periorbital Intervention
Acronym
Sleep Assessment Study by Periorbital Intervention
Scientific Title
Sleep Assessment Study by Periorbital Cooling
Scientific Title:Acronym
Sleep Assessment Study by Periorbital Intervention
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 effects of periorbital cooling on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Athens Insomnia Scale score
Key secondary outcomes
-Profile of Mood States
-Sleep indicators measured by an actigraphy device
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1. Observation period for 1 week.
2. Wearing a cooling eye mask before bedtime for 4 weeks.
Interventions/Control_2
1. Observation period for 1 week.
2. Wearing a cooling eye mask before bedtime 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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Female aged 20-59
2. Female who has mild sleep difficulties
3. sleep difficulties due to a hotness/heat-trapping sensation
4. Set air-conditioning temperature during sleep to>=27, or do not use air-conditioning
5. Reluctant or anxious about using air-conditioning all night due to reasons other than electricity cost or skin/throat dryness
Key exclusion criteria
1.History or current/past suspected sleep disorders or psychiatric conditions.
2.Suspected hypersomnia, sleep apnea, or parasomnias.
3.Sleep is markedly disturbed by pain, itching, fever, diarrhea, frequent urination, etc.
4.Sleep may be significantly affected by allergic rhinitis/pollinosis or similar allergies.
5.History/current suspected cardiovascular disease, neurologic disease, or alcohol dependence.
6.Current smokers (past smoking allowed).
7.Regular use of medications/supplements related to sleep, stress, or fatigue.
8.Drinking exceeding "appropriate alcohol intake" (about 20 g pure alcohol/day on average; 500mL beer or 180 mL Japanese sake) on >=3 days/week, or habitual night drinking.
9.Sleep <5 hours/day or sleep schedule shifts (>=2 hours) between weekdays and weekends.
10.Shift work or likely schedule change during the study (e.g., overseas business trips).
11.Contraindications to eye mask use (eye/periorbital disease, inflammation, injury, swelling, eczema, etc.).
12.Ophthalmology visits in the last month or planned within 3 months due to eye disease/infection/glaucoma/retinal disease, etc. (minor visits such as contact lens prescriptions excluded).
13.Dislike/resistance to cooling the eye area.
14.Dislike/resistance to using an eye mask during sleep.
15.Dislike/resistance to mint/eucalyptus scent or menthol-containing eye masks.
16.Alcohol sensitivity.
17.History of allergic reactions to drugs/cosmetics (rash, redness, itching, dermatitis, etc.).
18.Past negative experience or skin trouble from using an eye mask, etc.
19.Pregnant, possibility of pregnancy, or planning pregnancy during the study.
20.Dislike/resistance to wearing an actigraphy device on the waist during sleep.
21.Currently enrolled in other studies, enrolled within the past 30 days, or expected to enroll in other studies during this study.
22.Other reasons making the participant inappropriate per the principal investigator (e.g., major protocol noncompliance).
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kitano |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8405
kjitano.junko@kao.com
Public contact
Name of contact person
| 1st name | Jenru |
| Middle name | |
| Last name | Chen |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8418
Homepage URL
chin.teiju@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
| 2026 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071557
