Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT01241604
Status:
TERMINATED
Last Update Posted:
2019-04-09
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Sponsor:
Philips Respironics
Organization:
Study Overview
Official Title:
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sub par recruitment performance
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SV3-ST
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: