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

NCT07157696 | Not Yet Recruiting DMC

• 1 other identifier: HOME- Oxygen Trial
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• dyspnea modification

  Change from the enrollment in the study to 6 weeks in dyspnea level measured by the modified Medical Research Council (mMRC) scale

  Change from the enrollment in the study to 6 weeks

Study Arms (2)

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

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.

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

Interventions

High-Flow Nasal Cannula (HFNC) Oxygen Therapy DEVICE

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.

High flow nasal cannulae treatment; Oxygen low therapy

Oxygen therapy DEVICE

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.

High flow nasal cannulae treatment; Oxygen low therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Life expectancy \< 3 months Inability to comply with home follow-up procedures.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Arcispedale S. Anna, Ferrara: collaborator
• University Hospital of Ferrara: collaborator

Related Publications (2)

• 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.

  PMID: 29283682 RESULT

• Weinreich 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.

  PMID: 36366859 RESULT

MeSH Terms

Conditions

Heart Diseases; Lung Diseases

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Central Study Contacts

Savino Spadaro, Associate professor

CONTACT

+393894841243; spdsvn@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share