Abstract
Study objectivesA recent study challenged the prevailing clinical view that maintaining inspiratory positive airway pressure (IPAP) is necessary for upper airway patency, demonstrating no differences in apnea hypopnea index (AHI) between continuous PAP (CPAP) with and without a resistor to reduce IPAP. In this study, we assessed the effect of Kairos PAP (KPAP), a new algorithm which features multiple drops in IPAP, only returning to therapeutic pressure near the end expiration, on sleep apnea severity and subjective comfort. MethodsTwo randomized clinical trials were conducted. In the Efficacy trial, the effect of KPAP vs. CPAP on AHI in PAP-treated OSA patients was examined using a split-night design, adjusting for period, sequence and fraction of supine sleep (mixed models). Unintentional leak differences between treatments were also examined. Exploratory analyses assessed the effect of KPAP vs. CPAP on key polysomnography outcomes. In the Comfort trial, we tested subjective preference for KPAP vs. CPAP at 9 and 13 cmH2O in PAP-naïve OSA patients. ResultsIn the Efficacy trial (N = 48), KPAP reduced AHI more than CPAP (mean difference [95%CI]: −0.5 [−0.8, −0.2] events/h, P = 0.007). Unintentional leak was also reduced by over 50 % (−2.5 [−3.2, −1.7] L/min, P < 0.001). No significant change was observed in the exploratory variables assessed. In the Comfort trial (N = 150), 69 [61, 77] % and 84 [77, 89] % of participants preferred KPAP over CPAP at 9 and 13 cmH2O, respectively (P < 0.001). ConclusionsKPAP is as effective as CPAP in reducing respiratory events, but is more comfortable and potentially better tolerated.
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