AVAPS-AE Efficacy Study

Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.

Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.

The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe.

Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep.

The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale.

The average number of hours ventilator was used per each day used.

Average number of days used per week

Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use.

Oxygen saturation measurements as determined by pulse oximetry

Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night.

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Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep.

Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep.

The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.

Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)

To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms.

Some users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks.