Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062565) titled 'The study on how differences in housing insulation performance affect sleep quality' on Aug. 13.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Dose comparison

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Sleel Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to quantitatively clarify the impact of housing insulation performance on sleep architecture. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intervention 1 (High-insulation condition): Overnight stay in a trailer house bedroom with Thermal Insulation Performance Grade 7 Interventions/Control_2 - Intervention 2 (Standard insulation conditions): Overnight stay in a trailer house bedroom with Insulation Performance Grade 4.

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - Males aged 20 to 39 at the time of registration Healthy adults (confirmed via medical questionnaire and physical assessment) Individuals who have received an explanation regarding the study's purpose, methods, and risks, and who have provided voluntary written consent Individuals capable of keeping a sleep diary and wearing an activity monitor for one week prior to the start of the experiment, and who can adhere to designated bedtimes and wake-up times (within+/-30 minutes) Individuals capable of staying overnight at the research facility for three consecutive nights Individuals capable of understanding explanations and completing questionnaires in Japanese Key exclusion criteria - Individuals showing a 3% ODI more than 5 events/hour or a minimum SpO2<90% on overnight pulse oximetry Individuals with an ESS score of 11 or higher Individuals suspected of having insomnia, circadian rhythm sleep-wake disorders, sleep-related movement disorders, etc., based on medical history Regular users of medications affecting sleep, such as hypnotics or psychotropic drugs Individuals currently undergoing treatment for psychiatric, neurological, or endocrine disorders, or those with severe cardiac or respiratory disease Shift workers or individuals planning travel involving a time difference of 3 hours or more during the study period Individuals with skin conditions or allergies at the sites where electrodes or sensors are to be attached Individuals currently participating in other studies, or those otherwise deemed unsuitable by the principal investigator Target Size - 28

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 14 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071608

Disclaimer: Curated by HT Syndication.