Clinical Trial: Effects of different mattress toppers on body pressure distribution and RMSSD during supine rest: a randomized crossover study (Japan)

Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063099) titled 'Effects of different mattress toppers on body pressure distribution and heart rate variability during supine rest' on Sept. 29.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Fukui Health Science University

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

Objective: Narrative objectives1 - To compare body pressure distribution and the heart rate variability index RMSSD during supine rest under three different mattress topper conditions, and to examine within-participant associations between body pressure distribution and RMSSD. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Standard condition: Participants rested supine with their eyes closed for 10 minutes in a darkened room on a mattress topper (nobirakuPro, Yumeron Kurokawa, Fukui, Japan) containing approximately 27 cylindrical urethane cushions. A 10-minute seated washout period in a bright room was provided between intervention conditions. Interventions/Control_2 - Firm condition: Participants rested supine with their eyes closed for 10 minutes in a darkened room on a mattress topper with the same cylindrical structure as the Standard condition but with material hardness increased by 40%. A 10-minute seated washout period in a bright room was provided between intervention conditions.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Healthy university students aged 18-20 years who provided written informed consent to participate in the study. Key exclusion criteria - Participants with persistent pain, a history of sleep or psychiatric disorders, use of medications affecting autonomic function, or skin disorders preventing sensor attachment were excluded. Target Size - 15

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 11 Month 03 Day Date of IRB - 2025 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 12 Month 18 Day Last follow-up date - 2025 Year 12 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072233

Disclaimer: Curated by HT Syndication.