Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

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.

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

Inclusion Criteria:

• Age 21-80.
• Ability to provide consent.
• Documentation of medical stability by investigator.
• Currently using BiPAP S/T (At least 4 weeks on therapy).
• Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.

Exclusion Criteria:

• Participants, who are acutely ill, medically complicated or who are medically unstable.
• Participants in whom PAP therapy is otherwise medically contraindicated.
• Participants who are unwilling to wear PAP.
• Participants who are currently prescribed oxygen therapy.
• 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 Periodic Limb Movement (PLM) Arousal Index > 15).
• Participants who are unwilling to participate in the study.