A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea.
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).
Antic
Nick A
NA
Adelaide Institute for Sleep Health, RGH, 202-16 Daws Road, Daw Park, SA 5041, Australia. nick.antic@health.sa.gov.au
Buchan
Catherine
C
Esterman
Adrian
A
Hensley
Michael
M
Naughton
Matthew T
MT
Rowland
Sharn
S
Williamson
Bernadette
B
Windler
Samantha
S
Eckermann
Simon
S
McEvoy
R Doug
RD
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*