Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060425) titled 'Effects of differences in response speed of breath-synchronized function of HiSanso Portable alfa II on improving oxygenation during six-minute walk test' on Jan. 21.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Other

Condition: Condition - interstitial lung disease and chronic obstructive pulmonary disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate whether improving the response speed of the respiratory synchronization function in the respiratory synchronizer of HiSanso Portable alfa II contributes to improving oxygenation during six-minute walk test Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - A modified version of the respiratory synchronizer with improved response speed for its respiratory synchronization function is used. Interventions/Control_2 - A respiratory synchronizer with standard respiratory synchronization functionality is used.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Drug therapy is not restricted. 2. Cases with interstitial lung disease or chronic obstructive pulmonary disease. 3. Cases using home oxygen therapy during exertion or with a minimum SpO2 below 90% during six-minute walk test performed in room air. Key exclusion criteria - 1. Cases with acute exacerbation or respiratory tract infection within the past four weeks, resulting in instability. 2. Cases with new pneumothorax within the past four weeks, resulting in instability. 3. Cases with unstable angina or myocardial infarction within the past four weeks. 4. Cases with chronic pneumothorax. 5. Cases with worsening of complications such as heart failure, bronchial asthma, or renal failure, resulting in instability. 6. Cases unable to perform the six-minute walk test due to dyspnea or similar reasons. 7. Cases requiring nasal oxygen flow exceeding 5 L/min during exertion. 8. Cases with peripheral circulatory disorders making SpO2 measurement difficult. 9. Other cases deemed inappropriate by the study investigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 19 Day Date of IRB - 2026 Year 01 Month 19 Day Anticipated trial start date - 2026 Year 04 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=R000068497

Disclaimer: Curated by HT Syndication.