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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
11
Mechanical Non-invasive Ventilation
Auto Servo Ventilation Device
Med One Medical Sleep Laboratory
Salt Lake City, Utah, United States
Apnea Hypopnea Index
The number of apneas and hypopneas per hour of sleep.
Time frame: 2 nights
Apnea Hypopnea Index- REM
The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).
Time frame: 2 nights
Central Apnea Index
The central apnea index is the number of central apneas divided by the number of hours of sleep.
Time frame: 2 nights
Obstructive Apnea Index
The obstructive apnea index is the number of obstructive apneas per hour of sleep.
Time frame: 2 nights
Mixed Apnea Index
The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.
Time frame: 2 nights
Hypopnea Index
The hypopnea index is number hypopneas per hour.
Time frame: 2 nights
Sleep Onset Latency
Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.
Time frame: 2 nights
REM Onset Latency
REM Onset Latency is the time it takes to fall into REM sleep.
Time frame: 2 nights
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wake After Sleep Onset
Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.
Time frame: 2 nights
Total Sleep Time
Total Sleep time is total amount of time a participant is asleep from lights off to lights on.
Time frame: 2 nights
Sleep Efficiency
Sleep Efficiency is the percentage of time spent asleep while in bed.
Time frame: 2 nights
Periodic Limb Movement Index
The periodic limb movement is the number of periodic limb movements per hour of sleep.
Time frame: 2 nights
Arousal Index
The arousal index is the number of arousals or awakenings per hour of sleep.
Time frame: 2 nights
Stages N1,N2,N3 and REM (R) Sleep (% TST)
The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.
Time frame: 2 nights
Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
The average amount of time spent N1, N2, N3 and REM in minutes per night.
Time frame: 2 nights
Nocturnal Oxygenation Index
Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Time frame: 2 nights
Apnea Hypopnea Index Using Modified Hypopnea Rule.
The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.
Time frame: 2 nights
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.
Time frame: 2 nights