NCT01241604

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (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 autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T 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

Primary Hypothesis and end-point: The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to: * Apnea-Hypopnea Index (AHI) Secondary Hypothesis and end-points: The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to: * Sleep Variables * REM, NREM and Total Sleep Time (TST) Indices * Apnea Hypopnea Index (AHI) * Center Apnea Index(CAI) * Obstructive Apnea Index (OAI) * Mixed Apnea Index (MAI) * Hypopnea Index (HI) * Sleep Onset Latency (SOL) * REM Onset Latency (ROL) * Wake After Sleep Onset (WASO) * Total Sleep Time (TST) * Sleep Efficiency (SE %) * Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes) * Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST) * Arousal Index \[total, AH-related, PLM-related, 'spontaneous'\] * Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study) * AHI (REM, NREM and TST) using modified hypopnea rule. * AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits

Conditions

• Sleep Disordered Breathing

Interventions

Type	Name	Description
DEVICE	BiPAP S/T	Mechanical Non-invasive Ventilation
DEVICE	BiPAP Auto SV3	Auto Servo Ventilation Device

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2010-11-16
• Last updated: 2019-04-09
• Results posted: 2019-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study