Long-Term Use of a Nasal Expiratory Positive Airway Pressure (EPAP) Device as a Treatment for Obstructive Sleep Apnea (OSA)

Abstract

Evaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA). A prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trial 13 sites including both academic and private sleep disorder centers OSA patients in the EPAP arm of the EPAP vs sham randomized study who used the EPAP device ≥ 4 h per night, ≥ 5 nights per week on average during months 1 and 2 of the 3-month trial and had ≥ 50% reduction in AHI or AHI reduction to < 10 documented by polysomnography, comparing the 3-month device-on PSG to the week-one device-off PSG. Treatment with a nasal EPAP device (N = 41) for 12 months. Polysomnography (PSG) on the patients wearing the device was performed after 12 months of treatment. The month 12 device-on PSG data from the analyzable subject cohort (N = 34) was compared to the week 1 device-off PSG from the EPAP vs sham trial. Of the 51 patients eligible, 34 were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events/h (week 1 device-off versus month 12 device-on). The decrease in the AHI (median) was 71.3% (p < 0.001). The median proportion of sleep time with snoring was reduced by 74.4% (p < 0.001). Over 12 months of EPAP treatment, the Epworth Sleepiness Scale decreased (11.1 ± 4.2 to 6.0 ± 3.2, p < 0.001), and the median percentage of reported nights used (entire night) was 89.3%. Nasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment. Long-term adherence to EPAP was excellent in those who had a positive clinical response at month 3 of the EPAP vs sham study. ClinicalTrials.gov TRIAL NAME: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E). URL: http://clinicaltrials.gov/ct2/show/NCT00849043?term=Ventus+Medical&rank=2. NCT00849043.