Sleep Apnea, Central, Sleep Disordered Breathing
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERespironics BiPAP autoSV2
Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.
DEVICERespironics BiPAP autoSV3
Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | 2 nights | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Apnea Index | 2 nights | 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. |
| Obstructive Apnea Index | 2 nights | 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. |
| Mixed Apnea Index | 2 nights | 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. |
| Hypopnea Index | 2 nights | 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. |
| Sleep Onset Latency | 2 nights | 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. |
| Rapid Eye Movement (REM) Onset Latency | 2 nights | 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. |
| Wake After Sleep Onset | 2 nights | 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. |
| Apnea Hypopnea Index- REM and NREM | 2 nights | 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. |
| Sleep Efficiency | 2 nights | 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. |
| Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | 2 nights | These measures are the amount of time patients spent in each stage of sleep in minutes. |
| Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | 2 nights | — |
| Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'] | 2 nights | 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. |
| Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) | 2 nights | Measure of oxygen saturation as measured by a pulse oximetry over the course of the night. |
| Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule. | 2 nights | 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. |
| Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits. | 2 nights | 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. |
| Total Sleep Time | 2 nights | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the investigators' sleep labs.
Pre-assignment details
Participants were excluded if they did not demonstrate an Apnea-Hypopnea Index (AHI) ≥ 10 and Central Apnea Index (CAI)≥ 5 during the diagnostic polysomnography (PSG), or if they did not demonstrate a CAI ≥ 5 on continuous positive airway pressure (CPAP) titration.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants who signed the informed consent | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening Phase With Diagnostic PSG | Screen Failure | 7 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 13.9 |
| Body Mass Index | 31 kg/m^2 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Apnea Hypopnea Index | 10.44 events/hour | Standard Deviation 10.3 |
| Respironics BiPAP autoSV3 | Apnea Hypopnea Index | 6.06 events/hour | Standard Deviation 5.81 |
Comparison: Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.p-value: 0.005495% CI: [1.44, 6.51]Wilcoxon Signed Rank test
Secondary
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
Population: Data was not scorable for NREM.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Respironics BiPAP autoSV2 | Apnea Hypopnea Index- REM and NREM | Apnea Hypopnea Index- REM | 3.27 events/hour | Standard Deviation 6.15 |
| Respironics BiPAP autoSV2 | Apnea Hypopnea Index- REM and NREM | Apnea Hypopnea Index- NREM | 6.84 events/hour | Standard Deviation 6.52 |
| Respironics BiPAP autoSV3 | Apnea Hypopnea Index- REM and NREM | Apnea Hypopnea Index- REM | 2.09 events/hour | Standard Deviation 3.74 |
| Respironics BiPAP autoSV3 | Apnea Hypopnea Index- REM and NREM | Apnea Hypopnea Index- NREM | 11.74 events/hour | Standard Deviation 11.7 |
Secondary
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
Population: This was not part of the standard scoring of the PSG, therefore this was not calculated
Secondary
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
Population: During scoring of the PSG the modified hypopnea rule wasn't utlized therefore this data is not provided.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'] | 26.04 events per hour | Standard Deviation 11.11 |
| Respironics BiPAP autoSV3 | Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'] | 23.58 events per hour | Standard Deviation 10.59 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Central Apnea Index | 2.82 events/hour | Standard Deviation 3.72 |
| Respironics BiPAP autoSV3 | Central Apnea Index | 0.56 events/hour | Standard Deviation 0.71 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Hypopnea Index | 5.11 events/hour | Standard Deviation 6.22 |
| Respironics BiPAP autoSV3 | Hypopnea Index | 4.16 events/hour | Standard Deviation 4.97 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Mixed Apnea Index | 0.44 events/hour | Standard Deviation 0.69 |
| Respironics BiPAP autoSV3 | Mixed Apnea Index | 0.20 events/hour | Standard Deviation 0.37 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Respironics BiPAP autoSV2 | Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) | Lowest Nocturnal oxygenation (%) | 86.54 percentage of oxygen saturation | Standard Deviation 8.74 |
| Respironics BiPAP autoSV2 | Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) | Baseline Nocturnal oxygenation (%) | 95.78 percentage of oxygen saturation | Standard Deviation 1.18 |
| Respironics BiPAP autoSV3 | Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) | Baseline Nocturnal oxygenation (%) | 95.7 percentage of oxygen saturation | Standard Deviation 1.43 |
| Respironics BiPAP autoSV3 | Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) | Lowest Nocturnal oxygenation (%) | 87.84 percentage of oxygen saturation | Standard Deviation 4.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Obstructive Apnea Index | 2.04 events/hour | Standard Deviation 2.35 |
| Respironics BiPAP autoSV3 | Obstructive Apnea Index | 1.14 events/hour | Standard Deviation 1.59 |
Secondary
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
Population: This data was not part of the scoring PSG criteria and therefore not collected.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Sleep Efficiency | 76.84 percentage efficiency | Standard Deviation 13.39 |
| Respironics BiPAP autoSV3 | Sleep Efficiency | 76.46 percentage efficiency | Standard Deviation 11.93 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Sleep Onset Latency | 18.91 minutes | Standard Deviation 18.53 |
| Respironics BiPAP autoSV3 | Sleep Onset Latency | 20.91 minutes | Standard Deviation 16.76 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Respironics BiPAP autoSV2 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | Stage 2 | 54.54 minutes | Standard Deviation 11.62 |
| Respironics BiPAP autoSV2 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | REM | 15.5 minutes | Standard Deviation 6.35 |
| Respironics BiPAP autoSV2 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | Stage 3 | 13.25 minutes | Standard Deviation 9.81 |
| Respironics BiPAP autoSV2 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | TST | 361.23 minutes | Standard Deviation 72.55 |
| Respironics BiPAP autoSV2 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | Stage 1 | 16.72 minutes | Standard Deviation 11.79 |
| Respironics BiPAP autoSV3 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | TST | 370.59 minutes | Standard Deviation 61.19 |
| Respironics BiPAP autoSV3 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | Stage 1 | 16.02 minutes | Standard Deviation 9.19 |
| Respironics BiPAP autoSV3 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | Stage 2 | 55.06 minutes | Standard Deviation 11.99 |
| Respironics BiPAP autoSV3 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | Stage 3 | 11.75 minutes | Standard Deviation 10.29 |
| Respironics BiPAP autoSV3 | Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. | REM | 17.18 minutes | Standard Deviation 7.43 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Total Sleep Time | 361.23 minutes | Standard Deviation 72.55 |
| Respironics BiPAP autoSV3 | Total Sleep Time | 370.59 minutes | Standard Deviation 61.19 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP autoSV2 | Wake After Sleep Onset | 88.67 minutes | Standard Deviation 52.33 |
| Respironics BiPAP autoSV3 | Wake After Sleep Onset | 93.47 minutes | Standard Deviation 58 |
Secondary
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
Time frame: 2 nights
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Respironics BiPAP autoSV2 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | Stage 1 | 16.72 minutes | Standard Deviation 11.79 |
| Respironics BiPAP autoSV2 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | Stage 2 | 54.54 minutes | Standard Deviation 11.62 |
| Respironics BiPAP autoSV2 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | Stage 3 & 4 | 13.25 minutes | Standard Deviation 9.81 |
| Respironics BiPAP autoSV2 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | REM | 15.50 minutes | Standard Deviation 6.35 |
| Respironics BiPAP autoSV3 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | REM | 17.18 minutes | Standard Deviation 7.43 |
| Respironics BiPAP autoSV3 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | Stage 1 | 16.02 minutes | Standard Deviation 9.19 |
| Respironics BiPAP autoSV3 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | Stage 3 & 4 | 11.75 minutes | Standard Deviation 10.29 |
| Respironics BiPAP autoSV3 | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) | Stage 2 | 55.06 minutes | Standard Deviation 11.99 |