An interventional study of Respironics BiPAP autoSV2 and Respironics BiPAP autoSV3 in Sleep Disordered Breathing and Sleep Apnea, Central, sponsored by Philips Respironics. Completed at 5 sites in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Philips Respironics · Not applicable, Interventional, and Treatment
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 algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) 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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 44 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
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Pre-Study Inclusion Criteria:
Enrollment Inclusion Criteria:
or
Exclusion Criteria:
Participants who are acutely ill, medically complicated or who are medically unstable.
Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.
Device: Respironics BiPAP autoSV2 · Device: Respironics BiPAP autoSV3
Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.
Device: Respironics BiPAP autoSV2 · Device: Respironics BiPAP autoSV3
Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Also known as: Respironics BiPAP autoSV3 advanced
Apnea Hypopnea Index
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.
Time frame: 2 nights
Apnea Hypopnea Index- REM and NREM
The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement) A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM.
Time frame: 2 nights
Central Apnea Index
The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort. A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour.
Time frame: 2 nights
Obstructive Apnea Index
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway. A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour.
Time frame: 2 nights
Mixed Apnea Index
Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour.
Time frame: 2 nights
Hypopnea Index
Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour.
Time frame: 2 nights
Sleep Onset Latency
Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.
Time frame: 2 nights
Rapid Eye Movement (REM) Onset Latency
Rapid eye movement latency is the time from the sleep onset to the first epoch of REM sleep; therefore, it depends on the patient's sleep latency.
Time frame: 2 nights
Wake After Sleep Onset
Wake after sleep onset refers to periods of wakefulness occurring after defined sleep onset. This was calculated by adding the total number of minutes the participant was awake after sleep onset.
Time frame: 2 nights
Total Sleep Time
Total sleep time is the total time the participant was asleep after sleep onset. This is calculated by adding the total number of minutes the participant was asleep during the night after sleep onset.
Time frame: 2 nights
Sleep Efficiency
Sleep efficiency is a measure of how much a participant slept over the night. This is calculated by comparing the total sleep time and the total recording time \* 100.
Time frame: 2 nights
Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.
These measures are the amount of time patients spent in each stage of sleep in minutes.
Time frame: 2 nights
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
Time frame: 2 nights
Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']
The number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.
Time frame: 2 nights
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)
Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.
Time frame: 2 nights
Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.
This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.
Time frame: 2 nights
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.
Time frame: 2 nights
Participants were recruited from the investigators' sleep labs.
| Milestone | Screening Phase | BiPap Auto SV2 Device First, BiPap Auto SV3 Device Second | BiPap Auto SV3 Device First, BiPap AutoSV2 Device Second |
|---|---|---|---|
| Started | 44 | 0 | 0 |
| Completed | 37 | 0 | 0 |
| Not completed | 7 | 0 | 0 |
| Withdrew: Screen failure | 7 | 0 | 0 |
| Milestone | Screening Phase | BiPap Auto SV2 Device First, BiPap Auto SV3 Device Second | BiPap Auto SV3 Device First, BiPap AutoSV2 Device Second |
|---|---|---|---|
| Started | 0 | 20 | 17 |
| Completed | 0 | 20 | 17 |
| Not completed | 0 | 0 | 0 |
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.
| events/hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Apnea Hypopnea Index | 10.44 ± 10.3 | 6.06 ± 5.81 |
The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement) A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM.
| events/hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Apnea Hypopnea Index- REM | 3.27 ± 6.15 | 2.09 ± 3.74 |
| Apnea Hypopnea Index- NREM | 6.84 ± 6.52 | 11.74 ± 11.70 |
The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort. A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour.
| events/hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Central Apnea Index | 2.82 ± 3.72 | 0.56 ± .71 |
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway. A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour.
| events/hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Obstructive Apnea Index | 2.04 ± 2.35 | 1.14 ± 1.59 |
Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour.
| events/hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Mixed Apnea Index | 0.44 ± .69 | 0.20 ± 0.37 |
Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour.
| events/hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Hypopnea Index | 5.11 ± 6.22 | 4.16 ± 4.97 |
Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.
| minutes | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Sleep Onset Latency | 18.91 ± 18.53 | 20.91 ± 16.76 |
Rapid eye movement latency is the time from the sleep onset to the first epoch of REM sleep; therefore, it depends on the patient's sleep latency.
No measurements were reported for this outcome.
Wake after sleep onset refers to periods of wakefulness occurring after defined sleep onset. This was calculated by adding the total number of minutes the participant was awake after sleep onset.
| minutes | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Wake After Sleep Onset | 88.67 ± 52.33 | 93.47 ± 58 |
Total sleep time is the total time the participant was asleep after sleep onset. This is calculated by adding the total number of minutes the participant was asleep during the night after sleep onset.
| minutes | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Total Sleep Time | 361.23 ± 72.55 | 370.59 ± 61.19 |
Sleep efficiency is a measure of how much a participant slept over the night. This is calculated by comparing the total sleep time and the total recording time \* 100.
| percentage efficiency | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Sleep Efficiency | 76.84 ± 13.39 | 76.46 ± 11.93 |
These measures are the amount of time patients spent in each stage of sleep in minutes.
| minutes | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Stage 1 | 16.72 ± 11.79 | 16.02 ± 9.19 |
| Stage 2 | 54.54 ± 11.62 | 55.06 ± 11.99 |
| Stage 3 | 13.25 ± 9.81 | 11.75 ± 10.29 |
| REM | 15.5 ± 6.35 | 17.18 ± 7.43 |
| TST | 361.23 ± 72.55 | 370.59 ± 61.19 |
| minutes | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Stage 1 | 16.72 ± 11.79 | 16.02 ± 9.19 |
| Stage 2 | 54.54 ± 11.62 | 55.06 ± 11.99 |
| Stage 3 & 4 | 13.25 ± 9.81 | 11.75 ± 10.29 |
| REM | 15.50 ± 6.35 | 17.18 ± 7.43 |
The number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.
| events per hour | Respironics BiPAP autoSV2 | Respironics BiPAP autoSV3 |
|---|---|---|
| Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'] | 26.04 ± 11.11 | 23.58 ± 10.59 |
Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.
| percentage of oxygen saturation | Treatment Group 1 | Treatment Group 2 |
|---|---|---|
| Baseline Nocturnal oxygenation (%) | 95.78 ± 1.18 | 95.7 ± 1.43 |
| Lowest Nocturnal oxygenation (%) | 86.54 ± 8.74 | 87.84 ± 4.60 |
This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.
No measurements were reported for this outcome.
The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.
No measurements were reported for this outcome.
Collected over 3 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group 1 | — | 0/37 (0%) | 0/37 (0%) |
| Treatment Group 2 | — | 0/37 (0%) | 0/37 (0%) |
All participants who met inclusion/exclusion criteria were included in the baseline analysis.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 53.2 ± 13.9 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 5 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 36 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 32 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 37 |
| Body Mass Index(kg/m^2) | All Study Participants |
|---|---|
| Mean | 31 ± 6 |
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