Status:
COMPLETED
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
Lead Sponsor:
Philips Respironics
Conditions:
Sleep Disordered Breathing
Sleep Apnea, Central
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief 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 algorith...
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)....
Eligibility Criteria
Inclusion
- Pre-Study
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
- Enrollment
- • Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5
- or
- • Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.
Exclusion
- • Participants who are acutely ill, medically complicated or who are medically unstable.
- Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
- Participants in whom PAP therapy is otherwise medically contraindicated.
- Participants who are unwilling to wear CPAP
- Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
- Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
- Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Participants with untreated, non- Obstructive Sleep Apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index \> 15).
- Participants who are unwilling to participate in the study.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00720213
Start Date
August 1 2008
End Date
July 1 2009
Last Update
January 29 2019
Active Locations (5)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, United States, 72205
3
Mark G. Goetting
Portage, Michigan, United States, 49024
4
Ohio State University
Columbus, Ohio, United States, 43210