Diagnosis and management of sleep apnea by a clinical nurse: a noninferiority randomized clinical trial

Study Objectives: References for the evaluation of obstructive sleep apnea often exceed the sleep clinic's capacity. We aimed to assess the noninferiority of a nursecommunicated model compared with a traditional physician-led model for the initial management of uncomplicated obstructive sleep apnea in the sleep clinic. Methods: In this noninferiority, open-label randomized controlled trial, patients referred for the evaluation of uncomplicated obstructive sleep apnea (home sleep apnea test with respiratory event index 20 events/h) were randomized to a nurse-communicated or a physician-led management. The primary endpoint was noninferiority in the mean change from baseline of the Epworth Sleepiness Scale score at 3 and 6 months, assuming a noninferiority margin of -2.0 points. Secondary outcomes included quality of life (Quebec Sleep Questionnaire) and positive airway pressure adherence. Results: Two hundred participants were randomized to a nurse-communicated (n = 101) or physician-led management (n = 99). Overall, 48 participants were lost at follow-up (27.7% and 20.4% in the nurse-communicated and physician-led groups, respectively). Most participants were treated with positive airway pressure (78.2% and 80.6% in the nurse-communicated and physician-led management groups, respectively). There was substantial missing data for the Epworth Sleepiness Scale (33% and 58% at 3 and 6 months in the nurse-communicated group and 29% and 55% in the physician-led group) and Quebec Sleep Questionnaire (86% and 91% at 3 and 6 months and 79.6% and 85.7% in the physician-led group). The difference in mean change between groups for the Epworth Sleepiness Scale was -0.71 (95% confidence interval -2.25 to 0.83) at 3 months and -0.21 (95% confidence interval -1.85 to 1.45) at 6 months. Foreach domain of the Quebec Sleep Questionnaire at 3 and 6 months, the lower bound of the 95% confidence interval was greater than the prespecified noninferiority margin. Positive airway pressure adherence was similar between groups. Conclusions: Among patients with uncomplicated obstructive sleep apnea, nurse-communicated management was noninferior to physician-led management in terms of sleepiness, quality of life, and positive airway pressure adherence at 6 months.