NCT00720213

Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Disordered Breathing
• Sleep Apnea, Central

Interventions

Type	Name	Description
DEVICE	Respironics BiPAP autoSV2	Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.
DEVICE	Respironics BiPAP autoSV3	Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-07-22
• Last updated: 2019-01-29
• Results posted: 2019-01-29

Locations

5 sites across 1 country: United States