biostudies-literatureUnknown7(5)Kryger MH<h4>Study objectives</h4>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).<h4>Design</h4>A prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trial<h4>Setting</h4>13 sites including both academic and private sleep disorder centers<h4>Patients</h4>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.<h4>Interventions</h4>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.<h4>Measurements and results</h4>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%.<h4>Conclusions</h4>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.<h4>Clinical trial registration</h4>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.<h4>Registration number</h4>NCT00849043.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine449-53Bhttps://www.ebi.ac.uk/biostudies/studies/S-EPMC3190843biostudies-literatureLong-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).PMC3190843Kryger MHBerry RBMassie CAfalseLong-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).<h4>Study objectives</h4>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).<h4>Design</h4>A prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trial<h4>Setting</h4>13 sites including both academic and private sleep disorder centers<h4>Patients</h4>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.<h4>Interventions</h4>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.<h4>Measurements and results</h4>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%.<h4>Conclusions</h4>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.<h4>Clinical trial registration</h4>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.<h4>Registration number</h4>NCT00849043.2011-01-01T00:00:00Z2011 Oct2024-11-12T16:48:25.684Z2019-03-27T00:44:50ZS-EPMC31908432200333910.5664/JCSM.130410.5664/jcsm.1304