Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060963) titled 'Objective Thresholds of Stress-Induced Tachypnea for Unconscious Stress Detection and Development of a Respiratory Biofeedback System' on June 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Department of Psychosomatic Medicine, Kansai Medical University

Condition: Condition - Stress-related disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to establish objective thresholds for stress-induced tachypnea by assessing changes in respiratory rate and respiratory amplitude during a mental arithmetic stress task in healthy volunteers, in conjunction with physiological parameters including heart rate variability and skin conductance level. In addition, the feasibility of a system integrating tachypnea detection and vibration-based feedback based on these thresholds will be explored. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous measurements of respiratory function (respiratory rate and tidal volume), heart rate, and skin conductance levels will be taken during 5 minutes of rest and 5 minutes of stress induced by a calculation task.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - This study will be conducted in healthy volunteers. Key exclusion criteria - 1) Individuals currently undergoing medication or outpatient treatment 2) Individuals with mental disorders, such as cognitive impairment, that prevent them from communicating Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 15 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069762

Disclaimer: Curated by HT Syndication.