Description Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 7:57 PM
Ignite Modification Date: 2025-12-24 @ 7:57 PM
NCT ID: NCT01241604
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
Study: NCT01241604
Study Brief:
Protocol Section: NCT01241604