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Device

High-Flow Air + Oxygen Therapy for Lung Disease

N/A
Recruiting
Led By Sonye Danoff, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a peripheral blood saturation level above 80% with room air while seated
Diagnosed with one of the following respiratory diseases: COPD (40% < Forced Expiratory Volume (FEV1) < 80% confirmed from pulmonary function test (PFT) within the last year), ILD (Confirmed with radiographic imaging), PH (Confirmed with radiographic imaging)
Must not have
Has any of the following: unstable angina, recent revascularization, recent history of cerebrovascular accident
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 minutes
Awards & highlights

Summary

This trial is testing if high flow air can help COPD, Interstitial Lung Disease, and Pulmonary Hypertension patients breathe better by reducing the amount of oxygen required.

Who is the study for?
This trial is for adults aged 30 or older with certain lung diseases like COPD, ILD, or PH who need oxygen therapy at rest. They must have a history of stable heart rate and blood pressure, not be pregnant or breastfeeding, and haven't had recent cardiovascular issues.
What is being tested?
The study compares standard oxygen therapy to two new methods: one combines high-flow air with oxygen, and the other alternates between them. The goal is to see which method best maintains an oxygen saturation level of 95% during rest.
What are the potential side effects?
Potential side effects may include discomfort from nasal delivery devices, dryness in the nose or throat from airflow, possible shortness of breath if settings are not optimal, and fatigue due to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood oxygen level is above 80% without extra oxygen.
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I have been diagnosed with COPD, ILD, or PH based on tests.
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My heart rate and blood pressure are within normal ranges.
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I need oxygen therapy at 1-4 L/min when resting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had recent heart or stroke issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
Secondary study objectives
Dyspnea relief achieved with of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy

Trial Design

12Treatment groups
Experimental Treatment
Group I: Baseline followed by intervention 2fExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).
Group II: Baseline followed by intervention 2eExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).
Group III: Baseline followed by intervention 2dExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).
Group IV: Baseline followed by intervention 2cExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).
Group V: Baseline followed by intervention 2bExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).
Group VI: Baseline followed by intervention 2aExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).
Group VII: Baseline followed by intervention 1fExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).
Group VIII: Baseline followed by intervention 1eExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).
Group IX: Baseline followed by intervention 1dExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).
Group X: Baseline followed by intervention 1cExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).
Group XI: Baseline followed by intervention 1bExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).
Group XII: Baseline followed by intervention 1aExperimental Treatment2 Interventions
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,759 Total Patients Enrolled
Sonye Danoff, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Nasal Delivery of High-Flow Air and Oxygen Therapy (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04170062 — N/A
Shortness of Breath Research Study Groups: Baseline followed by intervention 2a, Baseline followed by intervention 1b, Baseline followed by intervention 1d, Baseline followed by intervention 2d, Baseline followed by intervention 2e, Baseline followed by intervention 1c, Baseline followed by intervention 1e, Baseline followed by intervention 1f, Baseline followed by intervention 2b, Baseline followed by intervention 2f, Baseline followed by intervention 1a, Baseline followed by intervention 2c
Shortness of Breath Clinical Trial 2023: Nasal Delivery of High-Flow Air and Oxygen Therapy Highlights & Side Effects. Trial Name: NCT04170062 — N/A
Nasal Delivery of High-Flow Air and Oxygen Therapy (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04170062 — N/A
~32 spots leftby Sep 2025
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