Abstract

Objectives: Prospective, two-arm, clinical pilot study. Methods: Fifty obstructive sleep apnea patients who failed continuous positive airway pressure (CPAP) therapy enrolled in a 30 night Provent trial. Polysomnography was performed prior to trial (baseline) and day 10 of the study using Provent. Epworth sleepiness scale (ESS), quality of life index, and snoring intensity were assessed day 0 and 30. Nasal obstruction was determined prior to trial by endoscopy. Subjects were divided based on nasal patency (control: obstruction 80% were excluded). Results: Forty-four patients completed the trial averaging 7.01± 0.66 hours/night of sleep and tolerating Provent 6.04± 1.3 hours/night (mean±SD). Control cohort (n = 24) showed statistically significant improvement in apnea-hypopnea index (AHI), oxygen saturation and snoring. Control cohort had greater mean reduction in AHI (11.7±3.2 P = 0.005), ESS (0.63±1.1 P = 0.59), snoring (2.6±1.1 P = 0.04), mean increase in oxygen saturation (0.08±0.03, P = 0.04), and quality of life outcomes (0.72±0.31 P = 0.60) when compared with the obstruction cohort, n = 20, (AHI 4.7±5.8 P = 0.44; ESS 2.5±0.96 P = 0.08; snoring 1.3±0.52 P = 0.90; oxygen saturation 0.04±0.02, P = 0.03; quality of life outcomes 0.63±0.24, P = 0.80) (mean difference ± standard error of difference). Acceptance as a long-term solution was equivalent between both groups (56%). Conclusions: Provent therapy was effective in reducing AHI in all patients. Patients without nasal obstruction had greater success in reducing AHI and snoring while improving quality of life and minimum oxygen saturation. Correction of nasal obstruction may be a valuable prerequisite for Provent therapy.

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