CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Respironics BiPAP autoSV2 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00720213
NCT00720213N/ACompleted
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Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device

Philips Respironics·interventional·Posted Jul 22, 2008·Updated Jan 29, 2019

In Brief

A clinical study evaluating Respironics BiPAP autoSV2 and Respironics BiPAP autoSV3 for Sleep Disordered Breathing and Sleep Apnea, Central. Completed, enrolled 44 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disordered Breathing, Sleep Apnea, Central
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.9 years ago

Interventions

Respironics BiPAP autoSV2device

Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Respironics BiPAP autoSV3device

Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.