Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device

Conditions
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Sleep Disordered Breathing, Sleep Apnea, Central

Intervention / Treatment
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* Device: Respironics BiPAP autoSV2
* Device: Respironics BiPAP autoSV3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3<br>Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second. | Device: Respironics BiPAP autoSV2<br>* Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.<br>Device: Respironics BiPAP autoSV3<br>* Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.<br>* Other names: Respironics BiPAP autoSV3 advanced;|
| Experimental: Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2<br>Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2. | Device: Respironics BiPAP autoSV2<br>* Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.<br>Device: Respironics BiPAP autoSV3<br>* Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.<br>* Other names: Respironics BiPAP autoSV3 advanced;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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'] | 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights | 
| 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. | 2 nights |