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A Randomized Controlled Trial of Nurse-led Care for Symptomatic Moderate–Severe Obstructive Sleep Apnea

¹ Adelaide Institute for Sleep Health, Repatriation General Hospital, Daw Park, South Australia; ² Department of Medicine, Flinders University, Bedford Park, South Australia; ³ Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Monash University, Melbourne, Victoria; ⁴ University of South Australia, Adelaide, South Australia; ⁵ Department of Respiratory and Sleep Medicine, John Hunter Hospital and School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales; and ⁶ Flinders Centre for Clinical Change and Health Care Research, Flinders University, South Australia, Australia

Correspondence and requests for reprints should be addressed to Nick Antic, Ph.D., M.B.B.S., F.R.A.C.P., c/o Adelaide Institute for Sleep Health, RGH, 202-16 Daws Road, Daw Park, SA, Australia 5041. E-mail: nick.antic{at}health.sa.gov.au

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.

Clinical trial registered with http://www.anzctr.org.au (ACTRN012605000064606)

Key Words: obstructive sleep apnea • nurse-led clinics

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject 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. What This Study Adds to the Field 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.