Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders.

Conditions
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Sleep Disordered Breathing, Sleep Apnea, Central

Intervention / Treatment
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* Device: BiPAP auto Advanced
* Device: BiPAP auto SV4


Participation Criteria
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Eligibility Criteria
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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).

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: BiPAP auto SV Advanced<br>BiPAP auto SV Advanced | Device: BiPAP auto Advanced<br>* Auto Servo Ventilation Device<br>* Other names: BiPAP Auto SV;|
| Experimental: BiPAP auto SV 4<br>Auto Servo Ventilation Device | Device: BiPAP auto SV4<br>* Auto Servo Ventilation Device<br>* Other names: BiPAP Auto SV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |