Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061334) titled 'An Exploratory Study of the Effects of Different Residential Insulation Specifications on Sleep (Winter)' on April 21.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - S'UIMIN Inc.

Condition: Condition - Healthy adults with subjective sleep dissatisfaction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will evaluate the effects of differences in residential insulation methods on sleep in healthy Japanese adult men and women aged 20 years or older and younger than 70 years who are dissatisfied with their sleep in daily life, using sleep measurement with an EEG device, monitoring of sympathetic nervous activity with a pulse wave device, blood pressure measurement, and subjective sleep assessment with sleep questionnaires. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will stay under Housing Condition 1 with a different insulation specification and undergo sleep measurement using an EEG device from bedtime until waking. In addition, sympathetic nervous activity will be monitored using a pulse wave device, blood pressure will be measured, and subjective sleep will be evaluated using sleep questionnaires. Interventions/Control_2 - Participants will stay under Housing Condition 2 with a different insulation specification and undergo sleep measurement using an EEG device from bedtime until waking. In addition, sympathetic nervous activity will be monitored using a pulse wave device, blood pressure will be measured, and subjective sleep will be evaluated using sleep questionnaires.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Healthy Japanese adult men and women aged 20 years to less than 70 years who are dissatisfied with their sleep, are engaged in full-time work including housework and childcare, are able to provide voluntary informed consent, have a habitual time in bed of more than 5 hours based on their usual self-reported bedtime and wake-up time, and are able to stay at the designated study venue for a specified period. Key exclusion criteria - Individuals currently receiving treatment for any disease, including medication, except those with mild chronic conditions such as hypertension, diabetes, hyperlipidemia, gout, or asthma whose symptoms are stable with medication and do not interfere with work. Individuals diagnosed with sleep disorders such as insomnia or sleep apnea who are taking sleep-inducing or insomnia medications, including over-the-counter drugs, or are being treated with CPAP or oral appliances. Individuals unable to restrict intake during the study period of foods for specified health uses, foods with functional claims, supplements, or health foods that may affect the study. Individuals suspected of having severe chronic or acute infectious disease. Individuals planning vaccination during the study period. Night-shift workers or rotating-shift workers. Individuals unable to avoid alcohol consumption and caffeine-containing beverages after 6 p.m. on EEG measurement days. Individuals whose habitual time in bed is less than 5 hours. Individuals with extremely irregular dietary habits. Individuals with a BMI of 30 or higher. Individuals currently participating in another clinical study of drugs or health foods, within one month after completion of such a study, or planning to participate in another clinical study after consenting to this study. Individuals unable to stay at the designated study venue for a specified period. Any other individuals judged by the principal investigator to be inappropriate for participation in this study. Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 11 Month 19 Day Date of IRB - 2025 Year 11 Month 26 Day Anticipated trial start date - 2025 Year 12 Month 08 Day Last follow-up date - 2026 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070170

Disclaimer: Curated by HT Syndication.