AVAPS-AE Efficacy Study

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome

Conditions
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Obesity Hypoventilation Syndrome

Intervention / Treatment
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* Device: AVAPS-AE Mode of Therapy
* Device: Respironics OnmiLab BiPAP S mode
* Device: Respironics OmniLab Advanced CPAP mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years of age; less than or equal to 70 years of age Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy BMI greater than or equal to 30 kg/m2 Daytime PaCO2 greater than or equal to 45 mmHg Apnea Hypopnea index (AHI) > 5 Daytime pH > 7.35 Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) > 70% Exclusion Criteria: Acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator Respiratory alkalosis (pH > 7.45), per investigator discretion Emergency admissions on chronic respiratory failure Hospitalization for respiratory exacerbation < 6 weeks prior to screening visit Participants in whom PAP therapy is otherwise medically contraindicated Impaired upper airway function. For example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of Non-invasive positive pressure ventilation (NPPV) Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVAPS-AE<br>AVAPS-AE Mode of ventilation | Device: AVAPS-AE Mode of Therapy<br>* AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.<br>|
| Active Comparator: Respironics OmniLab Advanced BiPAP S mode<br>OmniLab Advanced BiPAP S Mode of ventilation | Device: Respironics OnmiLab BiPAP S mode<br>* Currently cleared Non-Invasive Ventilation (NIV) therapy modality<br>|
| Active Comparator: Respironics OmniLab Advanced CPAP mode<br>OmniLab Advanced CPAP Mode of ventilation | Device: Respironics OmniLab Advanced CPAP mode<br>* Currently cleared NIV therapy modality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Screening & 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Screening & 6 weeks | 
| Ventilator Adherence - Average Hours | The average number of hours ventilator was used per each day used. | 6 weeks | 
| Ventilator Adherence - Days Used | Average number of days used per week | 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. | Screening & 6 weeks | 
| Room Air Sp02 Assessment Via Pulse Oximetry | Oxygen saturation measurements as determined by pulse oximetry | Screening & 6 weeks | 
| Nocturnal Transcutaneous Capnography (TcC02) | Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. . | 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. | 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. | 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. | 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) | 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. | 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. | Screening & 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OHS