Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: Apnea-Hypopnea Index (AHI) 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: Sleep Variables REM, NREM and Total Sleep Time (TST) Indices Apnea Hypopnea Index (AHI) Center Apnea Index(CAI) Obstructive Apnea Index (OAI) Mixed Apnea Index (MAI) Hypopnea Index (HI) Sleep Onset Latency (SOL) REM Onset Latency (ROL) Wake After Sleep Onset (WASO) Total Sleep Time (TST) Sleep Efficiency (SE %) Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes) Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST) Arousal Index [total, AH-related, PLM-related, 'spontaneous'] Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study) AHI (REM, NREM and TST) using modified hypopnea rule. AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits

Official Title
-----------------
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

Conditions
-----------------
Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Device: BiPAP S/T
* Device: BiPAP Auto SV3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21-80. Ability to provide consent. Documentation of medical stability by investigator. Currently using BiPAP S/T (At least 4 weeks on therapy). Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration. Exclusion Criteria: Participants, who are acutely ill, medically complicated or who are medically unstable. Participants in whom PAP therapy is otherwise medically contraindicated. Participants who are unwilling to wear PAP. Participants who are currently prescribed oxygen therapy. 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 Periodic Limb Movement (PLM) Arousal Index > 15). Participants who are unwilling to participate in the study.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 S/T<br>Control Arm using Respironics BiPAP S/T | Device: BiPAP S/T<br>* Mechanical Non-invasive Ventilation<br>* Other names: Respironics BiPAP S/T;|
| Active Comparator: Respironics BiPAP Auto SV3<br>Treatment arm using Respironics BiPAP Auto SV3 | Device: BiPAP Auto SV3<br>* Auto Servo Ventilation Device<br>* Other names: Respironics BiPAP auto SV Advanced;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index | The number of apneas and hypopneas per hour of sleep. | 2 nights | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |