Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device

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). The features of autoSV Advanced include an automatic expiratory
pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed
airway apnea, a modified auto backup rate which is proportional to subject's baseline
breathing rate, and a variable inspiratory support. Our primary aim was to compare the
performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional
servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).

Study Design: A prospective, multicenter, randomized, controlled trial.

Setting: Five sleep laboratories in the United States.

Participants: Thirty-seven participants were included.

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.