Rationale: Obstructive sleep apnea (OSA) is a prevalent disease. Often limited clinical resources result in long patient waiting lists. Simpler validated methods of care are needed. Objectives: To demonstrate that a nurse-led model of care can produce health outcomes in symptomatic moderate–severe OSA not inferior to physician-led care. Methods: A randomized controlled multicenter noninferiority clinical trial was performed. Of 1,427 potentially eligible patients at 3 centers, 882 consented to the trial. Of these, 263 were excluded on the basis of clinical criteria. Of the remaining 619, 195 met home oximetry criteria for high-probability moderate–severe OSA and were randomized to 2 models of care: model A, the simplified model, using home autoadjusting positive airway pressure to set therapeutic continuous positive airway pressure (CPAP), with all care supervised by an experienced nurse; and model B, involving two laboratory polysomnograms to diagnose and treat OSA, with clinical care supervised by a sleep physician. The primary end point was change in Epworth Sleepiness Scale (ESS) score after 3 months of CPAP. Other outcome measures were collected. Measurements and Main Results: For the primary outcome change in ESS score, nurse-led management was no worse than physician-led management (4.02 vs. 4.15; difference, –0.13; 95% confidence interval: –1.52, 1.25) given a prespecified noninferiority margin of –2 for the lower 95%confidence interval. There were also no differences between both groups in CPAP adherence at 3 months or other outcome measures. Within-trial costs were significantly less in model A. Conclusions: A simplified nurse-led model of care has demonstrated noninferior results to physician-directed care in the management of symptomatic moderate–severe OSA, while being less costly.
American Journal of Respiratory and Critical Care Medicine Vol. 179, Issue 6, p. 501-508