Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060124) titled 'Detection of Hypoxemia Using Continuous Home SpO2 Monitoring in Patients with Interstitial Lung Disease' on Jan. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - Interstitial Lung Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the sensitivity of continuous home SpO2 monitoring for detecting hypoxemia indicative of eligibility for home oxygen therapy, compared with the 6-minute walk test.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 20 years or older
Outpatients diagnosed with fibrotic interstitial lung disease and followed at the Department of Respiratory Medicine, Institute of Science Tokyo Hospital
Patients judged by the attending physician to be at potential risk of future disease progression
Patients who do not meet the criteria for initiation of home oxygen therapy at the time of enrollment
Patients who have provided written informed consent to participate in this study
Key exclusion criteria - Patients diagnosed with pulmonary hypertension
Patients whose SpO2 falls below 85% during the 6-minute walk test at the time of enrollment
Patients judged by the attending physician to have a poor prognosis that would preclude completion of the study period
Patients who have difficulty attending regular outpatient visits
Patients deemed unsuitable for participation in the study by the principal investigator or sub-investigators
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 18 Day
Anticipated trial start date - 2025 Year 12 Month 18 Day
Last follow-up date - 2027 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068761
Disclaimer: Curated by HT Syndication.
