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

Adelaide Institute for Sleep Health, RGH, 202-16 Daws Road, Daw Park, SA 5041, Australia.
American Journal of Respiratory and Critical Care Medicine (Impact Factor: 13). 02/2009; 179(6):501-8. DOI: 10.1164/rccm.200810-1558OC
Source: PubMed


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.
To demonstrate that a nurse-led model of care can produce health outcomes in symptomatic moderate-severe OSA not inferior to physician-led care.
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.
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.
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 (ACTRN012605000064606).

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    • "According to Thalhofer and Dorow (1997) CSA is characterized by repeated apnoeas during sleep resulting from loss of respiratory effort. OSA has been shown to increase the risk of motor vehicle accidents, hypertension and possibly stroke and heart failure (Antic et al 2009) and is prevalent around the world (table 2). "
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    • "These repeated arousals cause sleep fragmentation which leads to daytime sleepiness (Collop 2007). OSA has been shown to increase the risk of motor vehicle accidents, hypertension, stroke, heart disease and diabetes (Antic et al 2009, Collop 2007) and is prevalent around the world. The prevalence of OSA ranges from 2% to 7.5% depending on gender and race or location (Bearpark et al 1995, Bixler et al 2001, Ip et al 2001, 2004, Kim et al 2004, Lam et al 2007, Sharma et al 2006, Udwadia et al 2004, Young et al 1993). "
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