Acute Respiratory Failure (ARF), Cardiac Disease, Pulmonary Disease, Chronic Respiratory Failure
Conditions
Brief summary
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.
Interventions
DEVICEHigh-Flow Nasal Cannula (HFNC) Oxygen Therapy
Type: Device / Procedure Description: Humidified high-flow nasal cannula oxygen therapy delivered via a home device. Provides warmed (37°C), humidified air and supplemental oxygen at ≥30 L/min, titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use the device for ≥8 hours per day, preferably overnight. Special Features: Integrated remote monitoring system that automatically records flow, FiO₂, SpO₂, heart rate, and usage time, transmitting data to a secure cloud platform for clinical follow-up.
DEVICEOxygen therapy
Type: Device / Procedure Description: Standard long-term oxygen therapy delivered through conventional low-flow systems (e.g., nasal cannula or mask). Oxygen is titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use oxygen for ≥8 hours per day, preferably overnight. Special Features: No humidification, high-flow delivery, or remote monitoring capabilities.
Sponsors
Arcispedale S. Anna, Ferrara
University Hospital of Ferrara
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Adults (≥18 years) with chronic respiratory (e.g., COPD, interstitial lung disease) and/or cardiac disease (e.g., heart failure), Clinical indication for long-term oxygen therapy, Capability to manage home-based devices independently or with caregiver assistance Signed informed consent
Exclusion criteria
Life expectancy \< 3 months Inability to comply with home follow-up procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dyspnea modification | Change from the enrollment in the study to 6 weeks | Change from the enrollment in the study to 6 weeks in dyspnea level measured by the modified Medical Research Council (mMRC) scale |
Contacts
Primary ContactSavino Spadaro, Associate professor
Outcome results
None listed