New developments in the treatment of obstructive sleep apnoea.

Background. Nasal continuous positive airway pressure (NCPAP) is widely used as treatment for obstructive sleep apnoea. However, to date there are no randomised controlled trials of this therapy against a well matched control. We undertook a randomised prospective parallel trial of therapeutic NCPAP for obstructive sleep apnoea compared with a control group on subtherapeutic NCPAP. Methods. Men with obstructive sleep apnoea, defined as an Epworth sleepiness score of 10 or more and ten or more dips per h of more than 4% Sao2 caused by obstructive sleep apnoea on overnight sleep study, were randomly assigned therapeutic or subtherapeutic NCPAP (about 1 cm H2O) for 1 month. Primary outcomes were subjective sleepiness (Epworth sleepiness score), objective sleepiness (maintenance of wakefulness test), and SF-36 questionnaire measurements of self-reported functioning and well-being. Findings. 107 men entered the study: 53 received subtherapeutic NCPAP and 54 therapeutic NCPAP. Use of NCPAP by the two treatment groups was similar: 5.4 h (therapeutic) and 4.6 h (subtherapeutic) per night. Subtherapeutic CPAP did not alter the overnight number of Sao2 dips per h compared with baseline, and thus acted as a control. Therapeutic NCPAP was superior to subtherapeutic NCPAP in all primary outcome measures. The Epworth score decreased from a median of 15.5 to 7.0 on therapeutic NCPAP and from 15.0 to 13.0 on subtherapeutic nCPAP (between treatments, p<0.0001). Mean maintenance of wakefulness time increased from 22.5 to 32.9 min on therapeutic NCPAP and, not significantly, from 20.0 to 23.5 min on subtherapeutic NCPAP (between treatments, p<0.005). Effect sizes for SF-36 measures of energy and vitality were 1.68 (therapeutic) and 0.97 (subtherapeutic) NCPAP (between treatments, p<0.0001). For mental summary score the corresponding values were 1.02 and 0.4 (between treatments, p=0.002). Interpretation. Therapeutic NCPAP reduces excessive daytime sleepiness and improves self-reported health status compared with a subtherapeutic control. Compared with controls, the effects of therapeutic NCPAP are large and confirm previous uncontrolled clinical observations and the results of controlled trials that used an oral placebo. (Lancet 1999;353:2100–5)