Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058917) titled 'A Comparative Study to Establish Safe Use Methods and Verify the Effects of Hypoxic Chambers' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Healthy adults will be enrolled. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Hypoxic chambers have become widely used for the purpose of enhancing athletic performance. In recent years, their use has expanded to the general population for health promotion, and an increasing number of fitness gyms are now equipped with hypoxic chambers. However, cases of use in unmanned gyms and at home have also been observed, and standardized safety guidelines for their operation have not yet been established. Furthermore, the scientific evidence supporting claims of improvement in diabetes, hypertension, and obesity through continued use for commercial purposes remains limited.

This study aims to establish safety standards for the operation of hypoxic chambers and to verify their effectiveness in lifestyle-related diseases. We will conduct a questionnaire survey on hypoxia awareness among healthy individuals and implement a three-week intermittent hypoxic intervention using hypoxic chambers equipped with an original safety management system. The primary outcome measures will include psychological burden associated with hypoxic exposure, circadian blood glucose variability, blood pressure, and body weight. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will stay in a hypoxic chamber for 1 hour per day, 5 days per week, for 3 weeks. Interventions/Control_2 - Participants will stay in a hypoxic chamber for 1 hour per day, 5 days per week, for 3 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Healthy individuals without a history of cardiovascular, internal medicine, or respiratory diseases 2. Aged 20 years or older and 65 years or younger at the time of enrollment 3. Not on any regular medication 4. Able to provide written informed consent for study participation Key exclusion criteria - Participants meeting the following conditions will be excluded due to anticipated vulnerability or hypersensitivity to hypoxic exposure: 1. History of cardiovascular or respiratory disease, or currently under treatment for such conditions 2. Current smoking habit 3. History of an acute internal medicine illness (e.g., cold, bronchitis, or other infection) requiring medical consultation within the past two weeks

Participants meeting the following conditions will be excluded as they may affect the evaluation of effectiveness: 1. Currently under treatment for diabetes mellitus or hypertension 2. Regular use of medication 3. Claustrophobia 4. Metal allergy Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 10 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067296

Disclaimer: Curated by HT Syndication.