Tokyo, Oct. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059554) titled 'Understanding the effectiveness of mouth tape and its association with respiratory events in a capsule hotel type sleeping facility' on Oct. 30.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Kobayashi Pharmaceutical Co., Ltd. R&D Headquarters Personal and Home Care Development Department Wellness Care Development Group

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effectiveness of using mouth tape during sleep and its association with respiratory events Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Sleeping with mouth tape Interventions/Control_2 - Sleeping with mouth tape- > Sleeping without mouth tape

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - ･Subjects who are over 20 years old and under 60 years old at the time of obtaining consent ･Subjects staying overnight for 1 or 2days during the study period ･Subjects who fully understood and provided written consent after receiving an explanation about this study before participating in the study ･Subjects who agree to keep the difference in their bedtime and wake-up time between the first and second nights within one hour, as much as possible (applicable to two-night participants) Key exclusion criteria - ･Subjects whose BMI is below 18.5 or above 30.0 ･Subjects who wish to carry out the following items on the day of the test and during the test period-> Drinking alcohol, Excessive exercise, Caffeine intake after 6pm ･Subjects who regularly use some kind of medicine or treatment device･Subjects who are unable to put on and take offthis product voluntarily (such as those with dementia) ･Subjects who have used the test product and felt any abnormality ･Subjects whose sleep duration is extremely short (less than 6 hours) (for single-night participants). ･Subjects with a history of illness or treatment related to symptoms of nasal congestion or respiratory symptoms (within the past year) ･Subjects judged to be inappropriate by the person in charge of the research Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 14 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2025 Year 10 Month 30 Day Last follow-up date - 2026 Year 02 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068120

Disclaimer: Curated by HT Syndication.