This study evaluated the therapeutic performance of a new BiPAP auto Servo Ventilation (ASV) device (BiPAP auto SV Advanced©, Philips Respironics) for the treatment of Complex Central Sleep Apnea (CompCSA).
A prospective multicenter randomized controlled trial ongoing at 5 sites in the US; Subjects were recruited if they demonstrated an Apnea Hypopnea Index (AHI) ≥ 10 on their diagnostic polysomnogram (PSG) [AHI (mean +/− SD) 45+/−20; range 17.5–90; CAI 10 +/−11; range 0.0–54] and continued in the study if on their CPAP titration they had a Central Apnea Index (CAI) ≥ 5 [AHI 29 +/−17; range 9.5 –71; CAI 16 +/−15.5; range 5 –66]. Qualifying subjects were randomized to receive either a currently marketed device (BiPAP auto SV©, Philips Respironics) or the BiPAP autoSV Advanced device, with a modified auto back up rate and automatic EPAP adjustment.
To date, data from 32 consecutive subjects (27 males, mean age 64 y and 5 females, mean age 61 y) meeting all enrollment criteria are presented. Both devices were effective in treatment of CompCSA. Compared to CPAP and baseline Diagnostic PSG, treatment with the new BiPAP autoSV Advanced resulted in a statistically significant reduction in AHI and CAI (p <0.001). Additionally, the AHI, CAI, Obstructive Apnea Index (OAI) and the Hypopnea Index (HI) differed significantly (p<0.05) between BiPAP autoSV and BiPAP autoSV Advanced. Other key variables, including Arousal Index (AI), Mixed Apnea Index (MAI), Total Sleep Time (TST), Sleep Efficiency (SE%), Wake After Sleep Onset (WASO), and Baseline SpO2 and Low SpO2 did not differ significantly between devices.
These results indicate that recent improvements to current ASV technology will likely lead to the successful reduction or elimination of CompCSA in patients presenting with this condition, as evidenced by the clinically and statistically significant reductions in AHI and CAI from Diagnostic and CPAP nights.
The present study demonstrates the efficacy of a new device BiPAP auto SV Advanced© in treating complex sleep apnea.
Shahrokh Javaheri, University grant monies none; Grant monies (from sources other than industry) none; Grant monies (from industry related sources) I received grant from Respironics in regards to this reseach; Shareholder none; Employee none; Other I lecture for Respironics and Res Med 2 compnies that make servoventilation devices.; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. BipapAutoedSV,Advanced