Sleep Disordered Breathing
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEBiPAP S/T
Mechanical Non-invasive Ventilation
DEVICEBiPAP Auto SV3
Auto Servo Ventilation Device
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | 2 nights | The number of apneas and hypopneas per hour of sleep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Apnea Index | 2 nights | The central apnea index is the number of central apneas divided by the number of hours of sleep. |
| Obstructive Apnea Index | 2 nights | The obstructive apnea index is the number of obstructive apneas per hour of sleep. |
| Mixed Apnea Index | 2 nights | The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour. |
| Hypopnea Index | 2 nights | The hypopnea index is number hypopneas per hour. |
| Sleep Onset Latency | 2 nights | Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off. |
| REM Onset Latency | 2 nights | REM Onset Latency is the time it takes to fall into REM sleep. |
| Wake After Sleep Onset | 2 nights | Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep. |
| Total Sleep Time | 2 nights | Total Sleep time is total amount of time a participant is asleep from lights off to lights on. |
| Apnea Hypopnea Index- REM | 2 nights | The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep). |
| Periodic Limb Movement Index | 2 nights | The periodic limb movement is the number of periodic limb movements per hour of sleep. |
| Arousal Index | 2 nights | The arousal index is the number of arousals or awakenings per hour of sleep. |
| Stages N1,N2,N3 and REM (R) Sleep (% TST) | 2 nights | The average amount of time spent N1, N2, N3 and REM percent total sleep time per night. |
| Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | 2 nights | The average amount of time spent N1, N2, N3 and REM in minutes per night. |
| Nocturnal Oxygenation Index | 2 nights | 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. |
| Apnea Hypopnea Index Using Modified Hypopnea Rule. | 2 nights | The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule. |
| Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits. | 2 nights | The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits. |
| Sleep Efficiency | 2 nights | Sleep Efficiency is the percentage of time spent asleep while in bed. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from one site to evaluate software enhancements. The study enrolled patients in the spring of 2009.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants that were consented. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening Period | Screen Failure | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 59.4 years STANDARD_DEVIATION 9.2 |
| BMI | 28.8 kg/m^2 STANDARD_DEVIATION 3.8 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 11 | 0 / 5 | 0 / 3 |
Outcome results
Primary
Apnea Hypopnea Index
The number of apneas and hypopneas per hour of sleep.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Apnea Hypopnea Index | 19.24 events per hour | Standard Deviation 16.72 |
| Respironics BiPAP Auto SV3 | Apnea Hypopnea Index | 15.85 events per hour | Standard Deviation 17.24 |
p-value: 0.753Wilcoxon signed ranks test
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Apnea Hypopnea Index- REM | 10.16 events per hour | Standard Deviation 5.14 |
| Respironics BiPAP Auto SV3 | Apnea Hypopnea Index- REM | 4.21 events per hour | Standard Deviation 4.49 |
Secondary
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
Population: The Apnea Hypopnea Index (AHI) was analyzed and results were provided. However the epochs were not separated out as this is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.
Secondary
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
Population: The Apnea Hyopnea Index(AHI) was analyzed and results were provided. The AHI using the modified hypopnea rule was not conducted. This is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.
Secondary
Arousal Index
The arousal index is the number of arousals or awakenings per hour of sleep.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Arousal Index | 27.33 arousals per hour | Standard Deviation 14.3 |
| Respironics BiPAP Auto SV3 | Arousal Index | 23.76 arousals per hour | Standard Deviation 15.11 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Central Apnea Index | 0.14 events per hour | Standard Deviation 0.25 |
| Respironics BiPAP Auto SV3 | Central Apnea Index | 0.11 events per hour | Standard Deviation 0.14 |
Secondary
Hypopnea Index
The hypopnea index is number hypopneas per hour.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Hypopnea Index | 19.1 events per hour | Standard Deviation 16.54 |
| Respironics BiPAP Auto SV3 | Hypopnea Index | 15.74 events per hour | Standard Deviation 17.23 |
Secondary
Mixed Apnea Index
The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Mixed Apnea Index | 0 events per hour | Standard Deviation 0 |
| Respironics BiPAP Auto SV3 | Mixed Apnea Index | 0 events per hour | Standard Deviation 0 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Nocturnal Oxygenation Index | 24 oxygen saturation index | Standard Deviation 24.9 |
| Respironics BiPAP Auto SV3 | Nocturnal Oxygenation Index | 19.93 oxygen saturation index | Standard Deviation 19.97 |
Secondary
Obstructive Apnea Index
The obstructive apnea index is the number of obstructive apneas per hour of sleep.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Obstructive Apnea Index | 0 events per hour | Standard Deviation 0 |
| Respironics BiPAP Auto SV3 | Obstructive Apnea Index | 0 events per hour | Standard Deviation 0 |
Secondary
Periodic Limb Movement Index
The periodic limb movement is the number of periodic limb movements per hour of sleep.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Periodic Limb Movement Index | 7.32 movements per hour | Standard Deviation 10.4 |
| Respironics BiPAP Auto SV3 | Periodic Limb Movement Index | 4 movements per hour | Standard Deviation 5.9 |
Secondary
REM Onset Latency
REM Onset Latency is the time it takes to fall into REM sleep.
Time frame: 2 nights
Population: This analysis was not done because this is not a standard measurement.
Secondary
Sleep Efficiency
Sleep Efficiency is the percentage of time spent asleep while in bed.
Time frame: 2 nights
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Sleep Efficiency | 74.78 percentage of time asleep | Standard Deviation 12.36 |
| Respironics BiPAP Auto SV3 | Sleep Efficiency | 73.42 percentage of time asleep | Standard Deviation 16.96 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Sleep Onset Latency | 43.25 minutes | Standard Deviation 41.98 |
| Respironics BiPAP Auto SV3 | Sleep Onset Latency | 64.58 minutes | Standard Deviation 81.64 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | Stage N1 | 7.17 minutes | Standard Deviation 10.46 |
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | Stage N2 | 271.33 minutes | Standard Deviation 70.03 |
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | Stage N3 | 15.25 minutes | Standard Deviation 28.02 |
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | REM | 37.92 minutes | Standard Deviation 32.74 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | REM | 37.67 minutes | Standard Deviation 17.44 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | Stage N1 | 4.83 minutes | Standard Deviation 3.33 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | Stage N3 | 17.25 minutes | Standard Deviation 23.01 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (in Minutes) | Stage N2 | 294.92 minutes | Standard Deviation 67.18 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (% TST) | Stage N1 | 2.16 percentage of TST per night | Standard Deviation 2.95 |
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (% TST) | Stage N2 | 82.48 percentage of TST per night | Standard Deviation 15.54 |
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (% TST) | Stage N3 | 4.1 percentage of TST per night | Standard Deviation 8.14 |
| Respironics BiPAP S/T | Stages N1,N2,N3 and REM (R) Sleep (% TST) | REM | 11.26 percentage of TST per night | Standard Deviation 8.13 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (% TST) | REM | 10.92 percentage of TST per night | Standard Deviation 4.8 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (% TST) | Stage N1 | 1.37 percentage of TST per night | Standard Deviation 0.82 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (% TST) | Stage N3 | 4.27 percentage of TST per night | Standard Deviation 8.06 |
| Respironics BiPAP Auto SV3 | Stages N1,N2,N3 and REM (R) Sleep (% TST) | Stage N2 | 83.44 percentage of TST per night | Standard Deviation 9.01 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Total Sleep Time | 331.83 minutes | Standard Deviation 66.7 |
| Respironics BiPAP Auto SV3 | Total Sleep Time | 352.67 minutes | Standard Deviation 63.5 |
Secondary
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
Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respironics BiPAP S/T | Wake After Sleep Onset | 72.58 minutes | Standard Deviation 63.25 |
| Respironics BiPAP Auto SV3 | Wake After Sleep Onset | 67.67 minutes | Standard Deviation 39.86 |