Tokyo, Feb. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060744) titled 'Effects of down comforters blended with functional fibers on subjective sleep quality and sleep EEG' on Feb. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Kawada Feather Co., Ltd.

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

Objective: Narrative objectives1 - This study conducts sleep trials using down comforters among healthy male and female participants. Each participant will sleep using either a down comforter blended with functional fibers or a control down comforter blended with non-functional rayon fibers. We will record subjective sleep indices via questionnaires and perform sleep EEG measurements during the night. The objective of this study is to verify whether significant differences exist between the two types of down comforters in terms of sleep brainwaves, subjective sleep quality, and the sense of recovery upon awakening. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants sleep for three weeks using only a down comforter blended with functional fibers as their bedding. Interventions/Control_2 - Participants sleep for three weeks using only a down comforter blended with standard rayon fibers (without functional properties) as their bedding.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Individuals with no history of psychiatric or sleep disorders who provided informed consent to participate in the study. 2. Individuals aged 18 years or older and under 70 years at the time of obtaining consent. 3. Individuals who own a smartphone or PC and can answer questionnaire online. Key exclusion criteria - 1. Individuals currently receiving treatment for chronic respiratory, cardiac, renal, or hepatic diseases. 2. Individuals with systemic skin diseases such as severe atopic dermatitis or psoriasis. 3. Individuals receiving systemic steroids or immunosuppressants. 4. Individuals with a daily habit of alcohol consumption, smoking, or caffeine intake. 5. Individuals who are not in an environment where they can sleep alone. 6. Individuals who use far-infrared radiating materials or similar materials in their daily bedding and clothing. 7. Individuals who do not use down comorters for their regular bedding. 8. Individuals deemed unsuitable by the principal investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 15 Day Date of IRB - 2026 Year 02 Month 19 Day Anticipated trial start date - 2026 Year 03 Month 03 Day Last follow-up date - 2026 Year 04 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069488

Disclaimer: Curated by HT Syndication.