Sleep quality improvement test by wearing Nerugoo (rechargeable hot eye mask)

UMIN ID: UMIN000056169

Registered date:15/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2024/11/16
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Wearing the test product for 5 days at a heated temperature - Washout period (1 week) - Wearing the test product for 5 days without heating
Wearing the test product for 5 days without heating - Washout period (1 week) - Wearing the test product for 5 days at a heated temperature

Outcome(s)

• Primary Outcome: Sleep quality (electroencephalogram measurement)
• Secondary Outcome: (Secondary outcomes) Sleep quality VAS questionnaire , OSA sleep inventory MA version (Safety evaluation) Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects who are under medication or outpatient treatment for some serious disease. 2) Subjects who are on exercise or diet therapy under the supervision of a physician. 3) Subjects who are likely to develop some adverse effects in their daily life due to the tested product. 4) Subjects with a current or previous history of drug or alcohol dependence. 5) Subjects who are currently visiting the hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or who have a history of mental illness in the past. 6) Subjects who have an irregular rhythm of life due to night work, shift work, etc. 7) Subjects who have an extremely irregular lifestyle in terms of eating, sleeping, etc. 8) Subjects who have an extremely picky eater. 9) Subjects with a serious current or previous illness such as brain disease, malignant tumor, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal gland disease, or other metabolic disease. 10) Subjects who use health foods, supplements, or medicines that affect the quality of sleep. 11) Subjects who use devices that claim to improve sleep quality, such as hot eye masks. 12) Subjects who have participated in other clinical trials (research) within 3 months prior to the date of consent, or have plans to participate in other clinical trials (research) during the study period. 13) Subjects with facial nerve disorder, skin sensory disorder, allergic constitution, skin disease, and atopic dermatitis, or sensitive skin. 14) Subjects who have undergone implantation surgery on the face due to bone fracture, plastic surgery, etc.

Related Information

• Primary Sponsor: Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
• Source(s) of Monetary Support: Lulu Inc.