Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062507) titled 'Sleep Assessment Study by Periorbital Intervention' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Kao Corporation

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of periorbital cooling on sleep. Basic objectives2 - Efficacy

Intervention: 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.

Eligibility: Age-lower limit - 20 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 =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 Size - 88

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071557

Disclaimer: Curated by HT Syndication.