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=

SUBMITTER: Berry RB 

PROVIDER: S-EPMC3065258 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature