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Sub par recruitment performance
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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respironics BiPAP S/T | Active Comparator | Control Arm using Respironics BiPAP S/T |
|
| Respironics BiPAP Auto SV3 | Active Comparator | Treatment arm using Respironics BiPAP Auto SV3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP S/T | Device | Mechanical Non-invasive Ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | The number of apneas and hypopneas per hour of sleep. | 2 nights |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 nights |
| Central Apnea Index | The central apnea index is the number of central apneas divided by the number of hours of sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brydon Grant, MD | Medical Director of Med One Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med One Medical Sleep Laboratory | Salt Lake City | Utah | 84121 | United States |
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Patients were recruited from one site to evaluate software enhancements. The study enrolled patients in the spring of 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Screening Population | All participants that signed consent are considered for the screening population. |
| FG001 | Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3 | Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device |
| FG002 | Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T | Auto Servo Ventilation Device and then Mechanical Non-invasive Ventilation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
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| ||||||||||||||||||
| Study Period |
|
The patients that were found eligible and were randomized are included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants that were consented. |
| 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 | The number of apneas and hypopneas per hour of sleep. | 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. | Posted | Mean | Standard Deviation | events per hour | 2 nights |
|
2 nights
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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 | Screening Period | All participants that were consented into the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Powers | Philips Respironics | 412-542-3669 | jeremy.powers@philips.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| BiPAP Auto SV3 | Device | Auto Servo Ventilation Device |
|
|
| 2 nights |
| Obstructive Apnea Index | The obstructive apnea index is the number of obstructive apneas per hour of sleep. | 2 nights |
| Mixed Apnea Index | The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour. | 2 nights |
| Hypopnea Index | The hypopnea index is number hypopneas per hour. | 2 nights |
| Sleep Onset Latency | Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off. | 2 nights |
| REM Onset Latency | REM Onset Latency is the time it takes to fall into REM sleep. | 2 nights |
| Wake After Sleep Onset | Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep. | 2 nights |
| Total Sleep Time | Total Sleep time is total amount of time a participant is asleep from lights off to lights on. | 2 nights |
| Sleep Efficiency | Sleep Efficiency is the percentage of time spent asleep while in bed. | 2 nights |
| Periodic Limb Movement Index | The periodic limb movement is the number of periodic limb movements per hour of sleep. | 2 nights |
| Arousal Index | The arousal index is the number of arousals or awakenings per hour of sleep. | 2 nights |
| 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. | 2 nights |
| 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. | 2 nights |
| 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. | 2 nights |
| 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. | 2 nights |
| 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. | 2 nights |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | events per hour | 2 nights |
|
|
|
| Secondary | Central Apnea Index | The central apnea index is the number of central apneas divided by the number of hours of sleep. | 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. | Posted | Mean | Standard Deviation | events per hour | 2 nights |
|
|
|
| Secondary | Obstructive Apnea Index | The obstructive apnea index is the number of obstructive apneas per hour of sleep. | 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. | Posted | Mean | Standard Deviation | events per hour | 2 nights |
|
|
|
| Secondary | Mixed Apnea Index | The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour. | 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. | Posted | Mean | Standard Deviation | events per hour | 2 nights |
|
|
|
| Secondary | Hypopnea Index | The hypopnea index is number hypopneas per hour. | 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. | Posted | Mean | Standard Deviation | events per hour | 2 nights |
|
|
|
| Secondary | Sleep Onset Latency | Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off. | 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. | Posted | Mean | Standard Deviation | minutes | 2 nights |
|
|
|
| Secondary | REM Onset Latency | REM Onset Latency is the time it takes to fall into REM sleep. | This analysis was not done because this is not a standard measurement. | Posted | 2 nights |
|
|
| Secondary | Wake After Sleep Onset | Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep. | 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. | Posted | Mean | Standard Deviation | minutes | 2 nights |
|
|
|
| Secondary | Total Sleep Time | Total Sleep time is total amount of time a participant is asleep from lights off to lights on. | 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. | Posted | Mean | Standard Deviation | minutes | 2 nights |
|
|
|
| Secondary | Sleep Efficiency | Sleep Efficiency is the percentage of time spent asleep while in bed. | 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. | Posted | Mean | Standard Deviation | percentage of time asleep | 2 nights |
|
|
|
| Secondary | Periodic Limb Movement Index | The periodic limb movement is the number of periodic limb movements per hour of sleep. | 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. | Posted | Mean | Standard Deviation | movements per hour | 2 nights |
|
|
|
| Secondary | Arousal Index | The arousal index is the number of arousals or awakenings per hour of sleep. | 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. | Posted | Mean | Standard Deviation | arousals per hour | 2 nights |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of TST per night | 2 nights |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | 2 nights |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | oxygen saturation index | 2 nights |
|
|
|
| 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. | 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. | Posted | 2 nights |
|
|
| 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. | 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. | Posted | 2 nights |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3 | Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device | 0 | 5 | 0 | 5 |
| EG002 | Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T | Auto Servo Ventilation Device first and then Mechanical Non-invasive Ventilation | 0 | 3 | 0 | 3 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Stage N3 |
|
| REM |
|
| Stage N3 |
|
| REM |
|