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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Blower-based High Flow Therapy delivered by nasal cannula
CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, United States
AHI Change (Therapy v Baseline)
Evaluate the change in AHI from baseline for HFT v CPAP therapy
Time frame: Acute - single night therapy exposure
Pulse Oxygen Saturation
Evaluate the mean, absolute minimum, absolute event-related nadir and mean nadir of pulse oxygen saturation during therapeutic polysomnography of HFT v CPAP
Time frame: Acute single night therapy exposure
Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)
Evaluate changes in sleep architecture on HFT and CPAP therapy as compared to baseline diagnostic polysomnography. Specifically, evaluate any difference between the therapies on %Wake Time (of SPT), % time in stages N1, N2, N3, REM (of TST), Minutes of Wake After Sleep onset, Sleep latency and REM Latency. Any difference in overall non-respiratory arousal index will be assessed.
Time frame: Acute single night therapy exposure
Respiratory Event Related Arousals
Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.
Time frame: Acute single night therapy exposure
Respiratory Disturbance Index (RDI)
Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.
Time frame: Acute single night therapy exposure
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