Clinical Trial: AVAPS-AE Efficacy Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Philips Respironics

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: Philips Respironics

Dates:
Date Received: May 23, 2011
Date Started: July 2011
Date Completion:
Last Updated: September 18, 2015
Last Verified: August 2015