1Sleep Disorders Center and Pulmonary Division, University Hospital Zurich, Zurich, Switzerland,2Zurich Center for Interdisciplinary Sleep Research, University of Zurich, Zurich, Switzerland,3Institute of Primary Care, University Hospital Zurich, University of Zurich, Zurich, Switzerland,4Sleep Disorders Center and Pulmonary Division, Cantonal Hospital St. Gallen, St. Gallen, Switzerland,5Sleep Disorders Center and Pulmonary Division, Zurich Rehabilitation Clinic, Wald, Switzerland,6Sleep Disorders Center and Pulmonary Division, City Hospital Triemli, Zurich, Switzerland,7Sleep Disorders Center and Pulmonary Division, Cantonal Hospital Munsterlingen, Munsterlingen, Switzerland,
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BackgroundThe obstructive sleep apnoea syndrome (OSAS) is conventionally treated by continuous positive airway pressure set at a fixed level (fCPAP). Automatic mask pressure adjustment (autoCPAP) is increasingly used during home therapy. We investigated whether autoCPAP is equivalent to fCPAP in improving sleepiness in patients with OSAS in the long-term.MethodsIn this multicentre equivalence trial, 208 patients with OSAS, with median Epworth sleepiness score (ESS) 13, apnoea/hypopnoea index 48.4/hour, were randomised to treatment with autoCPAP (5-15 mbar) or fCPAP (pressure set at the 90th percentile applied by autoCPAP during 2-4 weeks adaptation). Coprimary outcomes were changes in subjective and objective sleepiness from baseline to 2 years after treatment. Equivalence ranges were ±2 points in ESS and ±3 min sleep resistance time evaluated by recording responses to light signals.ResultsAt 2 years, in the intention to treat analysis, the reduction in sleepiness versus pretreatment baseline was similar in patients using autoCPAP (n=113, mean ESS-change −6.3, 95% CI −7.1 to −5.5; sleep resistance time +8.3 min, +6.9 to +9.7) and fCPAP (n=95, mean ESS-change −6.2, 95% CI −7.0 to −5.3; sleep resistance time +6.3 min, +4.7 to +7.8). The 95% CI of difference in ESS-reduction between autoCPAP and fCPAP was −0.9 to +1.4 and the 95% CI of difference in increase in sleep resistance time was −2.6 to +1.0 min. Blood pressure reduction and OSAS-related costs were similar between groups.ConclusionsAutoCPAP and fCPAP are equivalent within prespecified ranges in improving subjective and objective sleepiness in patients with OSAS over the course of 2 years. Costs of these treatments are similar.Trial registration numberClinicalTrials.gov NCT00280800.