Advanced Respiratory Monitoring and Oxygen Therapy in Chronically Ill Patients With Acute Respiratory Failure (HOME- Oxygen)

Università degli Studi di Ferrara

Status: Not yet enrolling

Conditions: Chronic Respiratory Failure; Cardiac Disease, Pulmonary Disease; Acute Respiratory Failure (ARF)

Treatments: Device: Oxygen therapy; Device: High-Flow Nasal Cannula (HFNC) Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07157696

HOME- Oxygen Trial

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

High flow nasal cannulae treatment

Experimental group

Description:

Participants assigned to this arm will receive home-based high-flow nasal cannula (HFNC) oxygen therapy using the myAirvo™3 device. The device delivers warm, humidified air with supplemental oxygen at a flow rate of ≥30 liters per minute, set at 37°C. Oxygen will be adjusted to maintain blood oxygen saturation (SpO₂) at or above 92%. • Group HFNC will receive HFNC during weeks 1-2, followed by a 2-day washout period, then low-flow oxygen during weeks 3-4, followed by a second 2-day washout period, and will resume HFNC during weeks 5-6

Treatment:

Device: Oxygen therapy

Device: High-Flow Nasal Cannula (HFNC) Oxygen Therapy

Oxygen low therapy

Active Comparator group

Description:

Participants assigned to this arm will receive standard long-term oxygen therapy delivered by a conventional low-flow oxygen device. Oxygen will be titrated to maintain blood oxygen saturation (SpO₂) at or above 92%. • Group low flow oxygen will receive low-flow oxygen during weeks 1-2, followed by a 2-day washout period, then HFNC during weeks 3-4, followed by a second 2-day washout period, and will resume low-flow oxygen during weeks 5-6.

Treatment:

Device: Oxygen therapy

Device: High-Flow Nasal Cannula (HFNC) Oxygen Therapy