Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060246) titled 'Effects of O2 Box on Sleep: An Open-Label Randomized Controlled Trial' on Jan. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Juntendo University

Condition: Condition - not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the effects of exposure to a hyperbaric oxygen environment on sleep Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Exposure to a hyperbaric oxygen chamber environment at 1.3 atmospheres (1 hour) Interventions/Control_2 - Do not enter the oxygen chamber

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1,At the time of consent acquisition, age is 18 years or older and 40 years or younger 2,Individuals who, after receiving sufficient explanation regarding participation in this research, provided written consent of their own free will based on full understanding Key exclusion criteria - 1,Individuals taking medications that affect sleep (such as sleeping pills) 2,Individuals planning to consume alcohol during the study period 3, Individuals suffering from diseases that cause sleep disorders 4, Individuals with a BMI of 30 or higher. 5, Individuals deemed unsuitable as research subjects by the principal investigator 6, Individuals who used this device within one week prior to the pre-observation date 7, Among the research subjects meeting the above (1), eligibility is determined by satisfying all (2) selection criteria and not meeting any (3) exclusion criteria. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 18 Day Date of IRB - 2025 Year 06 Month 30 Day Anticipated trial start date - 2026 Year 01 Month 05 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=R000068365

Disclaimer: Curated by HT Syndication.