The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS). The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
Currently cleared Non-Invasive Ventilation (NIV) therapy modality
Currently cleared NIV therapy modality
University of Arizona School of Medicine
Tucson, Arizona, United States
University of Chicago
Chicago, Illinois, United States
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Time frame: Screening & 6 weeks
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)
Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Time frame: Screening & 6 weeks
Apnea Hypopnea Index (AHI)
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.
Time frame: Screening & 6 weeks
Epworth Sleepiness Scale
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.
Time frame: Screening & 6 weeks
Severe Respiratory Insufficiency Questionnaire (SRIQ)
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.
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Time frame: Screening & 6 weeks
Ventilator Adherence - Average Hours
The average number of hours ventilator was used per each day used.
Time frame: 6 weeks
Ventilator Adherence - Days Used
Average number of days used per week
Time frame: 6 weeks
Actigraphy
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.
Time frame: Screening & 6 weeks
Room Air Sp02 Assessment Via Pulse Oximetry
Oxygen saturation measurements as determined by pulse oximetry
Time frame: Screening & 6 weeks
Nocturnal Transcutaneous Capnography (TcC02)
Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. .
Time frame: Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
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.
Time frame: Screening & 6 weeks
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency
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.
Time frame: Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices
The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.
Time frame: Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation
Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)
Time frame: Screening & 6 weeks
Reaction Time (Psychomotor Vigilance Test-PVT)
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.
Time frame: Screening & 6 weeks
Number of Participants With Need for Continued Oxygen Supplementation
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.
Time frame: Screening & 6 weeks