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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiPAP auto SV Advanced | Active Comparator | BiPAP auto SV Advanced |
|
| BiPAP auto SV 4 | Experimental | Auto Servo Ventilation Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP auto Advanced | Device | Auto Servo Ventilation Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep. | Baseline, and 2 nights (1 night for each intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahrokh Javaheri, MD | Sleepcare Diagnostics | Principal Investigator |
| Paul Wylie, MD | Arkansas Center for Sleep Medicine | Principal Investigator |
| Mark Goetting, MD | Sleep Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Center for Sleep Medicine | Little Rock | Arkansas | 72205 | United States | ||
| Sleep Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Screening Population | All patients that signed consent are considered for the screening population. |
| FG001 | BiPAP Auto SV Advanced First, Then BiPAP Auto SV 4 | Participants received the Philips BiPAP Auto SV Advanced for one night, then received the BiPAP Auto SV 4 for one night. |
| FG002 | BiPAP Auto SV 4 First, Then BiPAP Auto SV Advanced | Participants received the Philips BiPAP Auto SV 4 for one night, then received the BiPAP Auto SV Advanced for one night |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
|
| |||||||||||||||||||||
| Fist Intervention (Night 1) |
| ||||||||||||||||||||||
| Second Intervention (Night 2) |
|
All participants that signed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants that signed consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnea-Hypopnea Index (AHI) | Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | events per hour | Baseline, and 2 nights (1 night for each intervention) |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All Study participants that were consented to the study. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stents | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Powers | Philips | 412-542-3669 | jeremy.powers@philips.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| BiPAP auto SV4 | Device | Auto Servo Ventilation Device |
|
|
| Baseline, and 2 nights (1 night for each intervention) |
| Central Apnea Index(CAI) | Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep. | Baseline, and 2 nights (1 night for each intervention) |
| 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. | Baseline, and 2 nights (1 night for each intervention) |
| 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. | Baseline, and 2 nights (1 night for each intervention) |
| 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. | Baseline, and 2 nights (1 night for each intervention) |
| REM Onset Latency (ROL) | REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset. | Baseline, and 2 nights (1 night for each intervention) |
| 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. | Baseline, and 2 nights (1 night for each intervention) |
| 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 | Baseline, and 2 nights (1 night for each intervention) |
| Sleep Efficiency (SE %) | Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed. | Baseline, and 2 nights (1 night for each intervention) |
| 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. | Baseline, and 2 nights (1 night for each intervention) |
| 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. | Baseline, and 2 nights (1 night for each intervention) |
| Nocturnal Oxygenation | Nocturnal oxygenation measured by continuous pulse oximetry during sleep study. | Baseline, and 2 nights (1 night for each intervention) |
| Hypopnea Index (HI) | Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep. | Baseline, and 2 nights (1 night for each intervention) |
| Portage |
| Michigan |
| 49024 |
| United States |
| Sleepcare Diagnostics | Mason | Ohio | 45040 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 |
| BiPAP Auto SV 4 |
Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device |
|
|
|
| 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 | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | percent of TST | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| Secondary | Central Apnea Index(CAI) | Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep. | 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. | Posted | Mean | Standard Deviation | events per hour | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| 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. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | events per hour | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| 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. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | events per hour | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| 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. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | minutes | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| Secondary | REM Onset Latency (ROL) | REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset. | 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. | Posted | Baseline, and 2 nights (1 night for each intervention) |
|
|
| 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. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | minutes | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| 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 | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | minutes | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| Secondary | Sleep Efficiency (SE %) | Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | percent of time asleep | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| 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. | 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. | Posted | Baseline, and 2 nights (1 night for each intervention) |
|
|
| 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. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | events per hour | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| Secondary | Nocturnal Oxygenation | Nocturnal oxygenation measured by continuous pulse oximetry during sleep study. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | percent oxygen saturation | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| Secondary | Hypopnea Index (HI) | Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep. | 8 participants had missing or unscorable data, therefore they are not included in the analysis. | Posted | Mean | Standard Deviation | events per hour | Baseline, and 2 nights (1 night for each intervention) |
|
|
|
| 44 |
| 1 |
| 44 |
| 0 |
| 44 |
| EG001 | BiPAP Auto SV Advanced | All participants that received the Philips BiPAP Auto SV Advanced. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | BiPAP Auto SV 4 | All participants that received the Philips BiPAP Auto SV 4. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
|
| Stage 3 |
|
| REM |
|