NCT01860560

Non-Inferiority Trial of Acute HFT Versus nCPAP

Effect of High Flow Nasal Cannula (Flowrest®) on Mild-Moderate Sleep Disordered Breathing: A Non-Inferiority Study Versus Nasal Continuous Positive Airway Pressure (CPAP) Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vapotherm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).

Detailed description

Study to evaluate the acute efficacy of a single night of High Flow Therapy (HFT) to treat mild-moderate predominantly obstructive Sleep Disordered Breathing, as compared to nasal Continuous Positive Airway Pressure (CPAP) therapy. Subjects will be order-randomized to receive HFT or CPAP in the laboratory, undergo a washout period, and return for the alternative therapy in the laboratory. The hypothesis is that HFT will be non-inferior to CPAP in controlling Apnea/Hypopnea events in this subject set during this study. Primary outcome will be Apnea / Hypopnea Index (AHI) change on therapy as compared to baseline diagnostic polysomnography.

Conditions

• Mild-Moderate Obstructive Sleep Disordered Breathing

Interventions

Type	Name	Description
DEVICE	High-Flow Therapy	Blower-based High Flow Therapy delivered by nasal cannula
DEVICE	Continuous Positive Airway Pressure	CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-05-22
• Last updated: 2023-05-03

Locations

1 site across 1 country: United States