A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial

Abstract

Study objectives: Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).

Design: A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.

Setting: 19 sites including both academic and private sleep disorder centers

Patients: Obstructive sleep apnea with a pre-study AHI ≥10/hour

Interventions: Treatment with a nasal EPAP device (N=127) or similar appearing sham device (N=123) for 3 months. Polysomnography (PSG) was performed on 2 non-consecutive nights (random order: device-on, device-off) at week 1 and after 3 months of treatment. Analysis of an intention to treat group (ITT) (patients completing week 1 PSGs) (EPAP N=119, sham N=110) was performed.

Measurements and results: At week 1, the median AHI value (device-on versus device-off) was significantly lower with EPAP (5.0 versus 13.8 events/h, P<0.0001) but not sham (11.6 versus 11.1 events/h, P=NS); the decrease in the AHI (median) was greater (-52.7% vs. -7.3%, P<0.0001) for the ITT group. At month 3, the percentage decrease in the AHI was 42.7% (EPAP) and 10.1% (sham), P<0.0001. Over 3 months of EPAP treatment the Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P<0.0001), and the median percentage of reported nights used (entire night) was 88.2%.

Conclusions: The nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence.

Registrations: ClinicalTrials.gov. Trial name: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO). URL: http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1.

Registration number: NCT00772044.

Keywords: CPAP; Obstructive sleep apnea; expiratory positive airway pressure.

Figure 1

Nasal EPAP device. Single use valves are inserted into each nostril and sealed with adhesive.

Figure 2

Study design

Figure 3

Epworth Sleepiness Scale at baseline and after 3 months of treatment for the mITT analysis. There was a significant decrease in both the EPAP device and sham device groups. However, the decrease was significantly greater for the EPAP device. Similar results were noted for the group with an Epworth Sleepiness Scale ≥10 at baseline. The error bars are standard error of the mean.