Sleep Disordered Breathing Clinical Trial
Official title:
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
This study was conducted to evaluate the therapeutic performance of a new auto Servo
Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central
sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory
pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed
airway apnea, a modified auto backup rate which is proportional to subject's baseline
breathing rate, and a variable inspiratory support. Our primary aim was to compare the
performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional
servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).
Study Design: A prospective, multicenter, randomized, controlled trial.
Setting: Five sleep laboratories in the United States.
Participants: Thirty-seven participants were included.
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