title: A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  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).
authors.affiliation: Adelaide Institute for Sleep Health, RGH, 202-16 Daws Road, Daw Park, SA 5041, Australia. nick.antic@health.sa.gov.au
authors.forename: Nick A
authors.initials: NA
authors.lastname: Antic
authors.forename: Catherine
authors.initials: C
authors.lastname: Buchan
authors.forename: Adrian
authors.initials: A
authors.lastname: Esterman
authors.forename: Michael
authors.initials: M
authors.lastname: Hensley
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Naughton
authors.forename: Sharn
authors.initials: S
authors.lastname: Rowland
authors.forename: Bernadette
authors.initials: B
authors.lastname: Williamson
authors.forename: Samantha
authors.initials: S
authors.lastname: Windler
authors.forename: Simon
authors.initials: S
authors.lastname: Eckermann
authors.forename: R Doug
authors.initials: RD
authors.lastname: McEvoy
mesh_terms: D001315:Australia; D045422:Continuous Positive Airway Pressure; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010092:Oximetry; D017060:Patient Satisfaction; D017286:Polysomnography; D011788:Quality of Life; D012720:Severity of Illness Index; D020181:Sleep Apnea, Obstructive / Q000191:economics / Q000451:nursing*