Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device (AUTOSV3)
Sleep Disordered Breathing, Sleep Apnea, Central
About this trial
This is an interventional treatment trial for Sleep Disordered Breathing
Eligibility Criteria
Inclusion Criteria:
Pre-Study Inclusion Criteria:
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
Enrollment Inclusion Criteria:
• 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 Criteria:
• 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.
Sites / Locations
- University of Arizona
- Arkansas Center for Sleep Medicine
- Mark G. Goetting
- Ohio State University
- Sleepcare Diagnostics
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3
Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2
Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.
Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.