Sleep Apnea, Central, Sleep Disordered Breathing
Conditions
Brief summary
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
Detailed description
The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to: • Apnea-Hypopnea Index (AHI)
Interventions
DEVICEBiPAP auto Advanced
Auto Servo Ventilation Device
DEVICEBiPAP auto SV4
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 * Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5. OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration. * Agreement to undergo a full-night, in-lab research CPAP Titration * Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices
Exclusion criteria
* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure. * Systolic blood pressure \< 80 mm Hg at Baseline Visit. * Participants in whom PAP therapy is otherwise medically contraindicated. * Participants who are unwilling to wear CPAP * Currently prescribed oxygen therapy (as needed, nocturnal, or continuous * 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)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index \> 15).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | Baseline, and 2 nights (1 night for each intervention) | Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Apnea Index(CAI) | Baseline, and 2 nights (1 night for each intervention) | Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep. |
| Obstructive Apnea Index (OAI) | Baseline, and 2 nights (1 night for each intervention) | Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep. |
| Mixed Apnea Index (MAI) | Baseline, and 2 nights (1 night for each intervention) | Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep. |
| Sleep Onset Latency (SOL) | Baseline, and 2 nights (1 night for each intervention) | Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off. |
| REM Onset Latency (ROL) | Baseline, and 2 nights (1 night for each intervention) | REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset. |
| Wake After Sleep Onset (WASO) | Baseline, and 2 nights (1 night for each intervention) | Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep. |
| Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Baseline, and 2 nights (1 night for each intervention) | REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from lights out, or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode |
| Sleep Efficiency (SE %) | Baseline, and 2 nights (1 night for each intervention) | Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed. |
| Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep | Baseline, and 2 nights (1 night for each intervention) | Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from lights out, or bedtime, to the onset of sleep. |
| Arousal Index | Baseline, and 2 nights (1 night for each intervention) | Arousal Index is 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. |
| Nocturnal Oxygenation | Baseline, and 2 nights (1 night for each intervention) | Nocturnal oxygenation measured by continuous pulse oximetry during sleep study. |
| Hypopnea Index (HI) | Baseline, and 2 nights (1 night for each intervention) | Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep. |
| Total Sleep Time (TST) | Baseline, and 2 nights (1 night for each intervention) | Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from lights out, or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants that signed consent. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening Period | Screen Failure | 15 | 0 | 0 |
| Screening Period | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 61.71 years STANDARD_DEVIATION 13.4 |
| Body Mass Index (BMI) | 33.3 kg/m^2 STANDARD_DEVIATION 6.6 |
| 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 | 39 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 44 | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 1 / 44 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Apnea-Hypopnea Index (AHI)
Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Apnea-Hypopnea Index (AHI) | 38 events per hour | Standard Deviation 31 |
| BiPAP Auto SV Advanced | Apnea-Hypopnea Index (AHI) | 13 events per hour | Standard Deviation 17 |
| BiPAP Auto SV 4 | Apnea-Hypopnea Index (AHI) | 12 events per hour | Standard Deviation 18 |
p-value: 0.001nonparametric Wilcoxon Signed Rank test
Secondary
Arousal Index
Arousal Index is 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.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Arousal Index | 22 events per hour | Standard Deviation 12 |
| BiPAP Auto SV Advanced | Arousal Index | 16 events per hour | Standard Deviation 7 |
| BiPAP Auto SV 4 | Arousal Index | 16 events per hour | Standard Deviation 8 |
Secondary
Central Apnea Index(CAI)
Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis. 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Central Apnea Index(CAI) | 12 events per hour | Standard Deviation 15 |
| BiPAP Auto SV Advanced | Central Apnea Index(CAI) | 1 events per hour | Standard Deviation 2 |
| BiPAP Auto SV 4 | Central Apnea Index(CAI) | 1 events per hour | Standard Deviation 3 |
Secondary
Hypopnea Index (HI)
Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Hypopnea Index (HI) | 9 events per hour | Standard Deviation 9 |
| BiPAP Auto SV Advanced | Hypopnea Index (HI) | 11 events per hour | Standard Deviation 15 |
| BiPAP Auto SV 4 | Hypopnea Index (HI) | 8 events per hour | Standard Deviation 11 |
Secondary
Mixed Apnea Index (MAI)
Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Mixed Apnea Index (MAI) | 4 events per hour | Standard Deviation 7 |
| BiPAP Auto SV Advanced | Mixed Apnea Index (MAI) | 0.3 events per hour | Standard Deviation 0.6 |
| BiPAP Auto SV 4 | Mixed Apnea Index (MAI) | 0.6 events per hour | Standard Deviation 2 |
Secondary
Nocturnal Oxygenation
Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Nocturnal Oxygenation | 82 percent oxygen saturation | Standard Deviation 7 |
| BiPAP Auto SV Advanced | Nocturnal Oxygenation | 86 percent oxygen saturation | Standard Deviation 4 |
| BiPAP Auto SV 4 | Nocturnal Oxygenation | 84 percent oxygen saturation | Standard Deviation 5 |
Secondary
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices
REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from lights out, or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 1 | 22 percent of TST | Standard Deviation 14 |
| Continous Positive Airway Pressure Titriation | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 2 | 61 percent of TST | Standard Deviation 14 |
| Continous Positive Airway Pressure Titriation | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 3 | 5 percent of TST | Standard Deviation 8 |
| Continous Positive Airway Pressure Titriation | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | REM | 11 percent of TST | Standard Deviation 9 |
| BiPAP Auto SV Advanced | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | REM | 13 percent of TST | Standard Deviation 9 |
| BiPAP Auto SV Advanced | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 1 | 18 percent of TST | Standard Deviation 10 |
| BiPAP Auto SV Advanced | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 3 | 4 percent of TST | Standard Deviation 6 |
| BiPAP Auto SV Advanced | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 2 | 65 percent of TST | Standard Deviation 13 |
| BiPAP Auto SV 4 | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | REM | 14 percent of TST | Standard Deviation 11 |
| BiPAP Auto SV 4 | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 2 | 65 percent of TST | Standard Deviation 12 |
| BiPAP Auto SV 4 | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 3 | 5 percent of TST | Standard Deviation 6 |
| BiPAP Auto SV 4 | Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices | Stage 1 | 17 percent of TST | Standard Deviation 10 |
Secondary
Obstructive Apnea Index (OAI)
Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Obstructive Apnea Index (OAI) | 14 events per hour | Standard Deviation 10 |
| BiPAP Auto SV Advanced | Obstructive Apnea Index (OAI) | 1 events per hour | Standard Deviation 2 |
| BiPAP Auto SV 4 | Obstructive Apnea Index (OAI) | 2 events per hour | Standard Deviation 4 |
Secondary
REM Onset Latency (ROL)
REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: REM onset latency is not a standard set of sleep scores analyzed. This is not apart of the analysis, this is in the protocol by error. However the protocol was not amended.
Secondary
Sleep Efficiency (SE %)
Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Sleep Efficiency (SE %) | 82 percent of time asleep | Standard Deviation 13 |
| BiPAP Auto SV Advanced | Sleep Efficiency (SE %) | 81 percent of time asleep | Standard Deviation 12 |
| BiPAP Auto SV 4 | Sleep Efficiency (SE %) | 82 percent of time asleep | Standard Deviation 8 |
Secondary
Sleep Onset Latency (SOL)
Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Sleep Onset Latency (SOL) | 16.6 minutes | Standard Deviation 16.3 |
| BiPAP Auto SV Advanced | Sleep Onset Latency (SOL) | 19.3 minutes | Standard Deviation 10.1 |
| BiPAP Auto SV 4 | Sleep Onset Latency (SOL) | 24.3 minutes | Standard Deviation 20 |
Secondary
Total Sleep Time (TST)
Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from lights out, or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Total Sleep Time (TST) | 354.0 minutes | Standard Deviation 74.3 |
| BiPAP Auto SV Advanced | Total Sleep Time (TST) | 352.4 minutes | Standard Deviation 69.2 |
| BiPAP Auto SV 4 | Total Sleep Time (TST) | 368.1 minutes | Standard Deviation 64.6 |
Secondary
Wake After Sleep Onset (WASO)
Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continous Positive Airway Pressure Titriation | Wake After Sleep Onset (WASO) | 59.1 minutes | Standard Deviation 48 |
| BiPAP Auto SV Advanced | Wake After Sleep Onset (WASO) | 64.1 minutes | Standard Deviation 57.6 |
| BiPAP Auto SV 4 | Wake After Sleep Onset (WASO) | 54.2 minutes | Standard Deviation 29.3 |
Secondary
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from lights out, or bedtime, to the onset of sleep.
Time frame: Baseline, and 2 nights (1 night for each intervention)
Population: Data was not analyzed as number of minutes, as minutes is not a meaningful measurement. It is best measured respective to % TST in outcome measure 2. This was included in the protocol in error and the protocol was not amended.