Sleep evaluation using an electroencephalograph while using earplug-type products at home

UMIN ID: UMIN000056211

Registered date:20/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/11/20
• Target sample size: 14
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sleeping with heat-generating earplugs Sleeping with non-heating earplugs
Sleeping with non-heating earplugs on Sleeping with heating earplugs on

Outcome(s)

• Primary Outcome: Sleep measurement data

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 55years-old
• Gender: Male and Female
• Exclude criteria: BMI less than 18.5 or 30.0 or more Those with symptoms of sleep apnea syndrome or diagnosed with a sleep disorder Those who wish to participate in the following activities on the day of the study and during the study period Drinking alcohol Excessive exercise Caffeine intake after 6 p.m. Smoking Those who regularly use any medicine or use medical devices Those who are primarily responsible for childcare or elderly care Those who live with or keep pets Those who have used the test product in the past and experienced some abnormality when using it Those with ear disorders Those who are deemed inappropriate by the research staff

Related Information

• Primary Sponsor: Kobayashi Pharmaceutical Co., Ltd. Household Products Division Wellness Care R&D Group
• Secondary Sponsor: ASMARQ Co., Ltd.
• Source(s) of Monetary Support: None