AVAPS-AE Efficacy Study
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.
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.
|Obesity Hypoventilation Syndrome||Device: AVAPS-AE Mode of Therapy Device: Respironics OnmiLab BiPAP S mode Device: Respironics OmniLab Advanced CPAP mode|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome|
- Daytime partial pressure of carbon dioxide in arterial blood (PaCO2) [ Time Frame: Baseline measurement and after 6 weeks of therapy ]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 partial pressure of oxygen in arterial blood(Pa02) [ Time Frame: Baseline measurement and after 6 weeks of therapy ]Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP)after 6 weeks.
- Apnea Hypopnea Index (AHI) [ Time Frame: Baseline measurement and after 6 weeks of therapy ]The AHI,( the number of apneas and hypopneas per hour of sleep)will be evaluated during the baseline sleep study and the 6 week follow up sleep study.
- Epworth Sleepiness Scale [ Time Frame: Baseline measurement and after 6 weeks of therapy ]
- Severe Respiratory Insufficiency Questionnaire [ Time Frame: During screening assessment and after 6 weeks of therapy ]
- Ventilator Adherence [ Time Frame: Entire duration of 6 week ventilator therapy ]
- Actigraphy [ Time Frame: During Baseline sleep study and during 6 weeks of therapy ]
- Room Air Sp02 assessment via pulse oximetry [ Time Frame: During Baseline titration and after the 6 weeks of use ]
- Nocturnal Transcutaneous Capnography (TcC02) [ Time Frame: During Baseline sleep study and 6 week follow sleep study. ]
- Duration, efficiency and quality of sleep and sleepiness (derived from sleep study) [ Time Frame: During baseline sleep study and 6 week follow up sleep study ]
- Reaction time (Psychomotor Vigilance test-PVT) [ Time Frame: During baseline screening at 6 week follow up visit ]
- Need for continued daytime Oxygen supplementation [ Time Frame: Baseline screening and 2 week follow up visit ]
|Study Start Date:||July 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
AVAPS-AE Mode of ventilation
Device: AVAPS-AE Mode of Therapy
AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
Active Comparator: Respironics OmniLab Advanced BiPAP S mode
OmniLab Advanced BiPAP S Mode of ventilation
Device: Respironics OnmiLab BiPAP S mode
Currently cleared NIV therapy modality
Active Comparator: Respironics OmniLab Advanced CPAP mode
OmniLab Advanced CPAP Mode of ventilation
Device: Respironics OmniLab Advanced CPAP mode
Currently cleared NIV therapy modality
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368614
|United States, Arizona|
|University of Arizona School of Medicine|
|Tucson, Arizona, United States, 85723|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Sairam Parthasarathy, MD||Southern Arizona VA Healthcare|
|Principal Investigator:||Babak Mokhlesi, MD||University of Chicago|