Chronic Respiratory FailureHOME- OxygenNCT07157696
Advanced Respiratory Monitoring and Oxygen Therapy in Chronically Ill Patients With Acute Respiratory Failure
A study testing High-Flow Nasal Cannula (HFNC) Oxygen Therapy and Oxygen therapy in people with Chronic Respiratory Failure and Cardiac Disease, Pulmonary Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Respiratory Failure, Cardiac Disease, Pulmonary Disease, Acute Respiratory Failure (ARF)
- What is being tested?
- High-Flow Nasal Cannula (HFNC) Oxygen Therapy and Oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 5 Nov 2025to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy < 3 months
- Inability to comply with home follow-up procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Savino SPADARO
Ferrara, Italy, 44121
Savino Spadaro, MD, spdsvn@unife.it
About this study
Official title: Advanced Bedside Lung Imaging and Respiratory Muscle Monitoring for Respiratory Support Management in Chronically Ill Patients With Acute Respiratory Failure: From Hospital to Home
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.
Read more
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.
- Conditions
- Chronic Respiratory Failure, Cardiac Disease, Pulmonary Disease, Acute Respiratory Failure (ARF)
- Being tested
- High-Flow Nasal Cannula (HFNC) Oxygen Therapy, Oxygen therapy
- Medical subject headings
- Heart Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Cannula (HFNC) Oxygen TherapyDevice
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.
Oxygen therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannulae treatment | Experimental | 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 Receives: Device: High-Flow Nasal Cannula (HFNC) Oxygen Therapy; Device: Oxygen therapy |
| Oxygen low therapy | Active comparator | 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. Receives: Device: High-Flow Nasal Cannula (HFNC) Oxygen Therapy; Device: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyspnea modification
Change from the enrollment in the study to 6 weeks in dyspnea level measured by the modified Medical Research Council (mMRC) scale
Measured: Change from the enrollment in the study to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start5 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- S. Anna Hospital, University Hospital of Ferrara
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157696
- Sponsor's protocol ID
- HOME- Oxygen Trial
- Acronym
- HOME- Oxygen
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagata K, Kikuchi T, Horie T, Shiraki A, Kitajima T, Kadowaki T, Tokioka F, Chohnabayashi N, Watanabe A, Sato S, Tomii K. Domiciliary High-Flow Nasal Cannula Oxygen Therapy for Patients with Stable Hypercapnic Chronic Obstructive Pulmonary Disease. A Multicenter Randomized Crossover Trial. Ann Am Thorac Soc. 2018 Apr;15(4):432-439. doi: 10.1513/AnnalsATS.201706-425OC.
PubMed 29283682Weinreich UM, Burchardt C, Huremovic J. The effect of domiciliary high flow nasal cannula treatment on dyspnea and walking distance in patients with interstitial lung disease - A pilot study. Chron Respir Dis. 2022 Jan-Dec;19:14799731221137085. doi: 10.1177/14799731221137085.
PubMed 36366859