Advanced Respiratory Monitoring and Oxygen Therapy in Chronically Ill Patients With Acute Respiratory Failure

This study is testing whether a new type of home oxygen therapy, called high-flow nasal cannula (HFNC), can improve breathing comfort and quality of life for people with long-term lung or heart conditions who need oxygen after leaving the hospital. HFNC delivers warm, humidified oxygen at higher flow rates than standard oxygen therapy, which may reduce shortness of breath, improve sleep, and make daily activities easier. The therapy will be provided using the myAirvo™3 device, which also allows doctors to check patients' oxygen levels, heart rate, and symptoms remotely. All patients will also wear a small device (RootiREX) to monitor heart rhythm, sleep quality, and detect breathing pauses at night. Participants will try both treatments - HFNC and standard oxygen therapy - for short periods, in random order, so that researchers can directly compare the effects within the same patient. Each treatment period will last two weeks, with a short break in between. The main goal of the study is to see whether HFNC reduces shortness of breath (measured by the modified Medical Research Council scale). Other outcomes include comfort, sleep quality, quality of life, oxygen levels, and how well patients are able to use the devices at home. The study will last six weeks in total for each participant. Researchers expect that HFNC will improve breathing comfort, stabilize oxygen levels, and reduce the need for hospital visits during this time.

NCT Number	NCT07157696
Lead Sponsor	Università degli Studi di Ferrara Collaborators: S. Anna Hospital, University Hospital of Ferrara
Conditions	Chronic Respiratory Failure, Cardiac Disease, Pulmonary Disease, Acute Respiratory Failure (ARF)
Enrollment	16 participants
Start Date	2025-10-03
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-10-03