AVAPS-AE Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01368614
First received: May 23, 2011
Last updated: August 26, 2015
Last verified: August 2015

May 23, 2011
August 26, 2015
July 2011
July 2012   (final data collection date for primary outcome measure)
Daytime partial pressure of carbon dioxide in arterial blood (PaCO2) [ Time Frame: Baseline measurement and after 6 weeks of therapy ] [ Designated as safety issue: No ]
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP)after 6 weeks.
Not Provided
Complete list of historical versions of study NCT01368614 on ClinicalTrials.gov Archive Site
  • Daytime partial pressure of oxygen in arterial blood(Pa02) [ Time Frame: Baseline measurement and after 6 weeks of therapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Severe Respiratory Insufficiency Questionnaire [ Time Frame: During screening assessment and after 6 weeks of therapy ] [ Designated as safety issue: No ]
  • Ventilator Adherence [ Time Frame: Entire duration of 6 week ventilator therapy ] [ Designated as safety issue: No ]
  • Actigraphy [ Time Frame: During Baseline sleep study and during 6 weeks of therapy ] [ Designated as safety issue: No ]
  • Room Air Sp02 assessment via pulse oximetry [ Time Frame: During Baseline titration and after the 6 weeks of use ] [ Designated as safety issue: No ]
  • Nocturnal Transcutaneous Capnography (TcC02) [ Time Frame: During Baseline sleep study and 6 week follow sleep study. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reaction time (Psychomotor Vigilance test-PVT) [ Time Frame: During baseline screening at 6 week follow up visit ] [ Designated as safety issue: No ]
  • Need for continued daytime Oxygen supplementation [ Time Frame: Baseline screening and 2 week follow up visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
AVAPS-AE Efficacy Study
Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Obesity Hypoventilation Syndrome
  • 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.
  • Device: Respironics OnmiLab BiPAP S mode
    Currently cleared NIV therapy modality
  • Device: Respironics OmniLab Advanced CPAP mode
    Currently cleared NIV therapy modality
  • Experimental: AVAPS-AE
    AVAPS-AE Mode of ventilation
    Intervention: Device: AVAPS-AE Mode of Therapy
  • Active Comparator: Respironics OmniLab Advanced BiPAP S mode
    OmniLab Advanced BiPAP S Mode of ventilation
    Intervention: Device: Respironics OnmiLab BiPAP S mode
  • Active Comparator: Respironics OmniLab Advanced CPAP mode
    OmniLab Advanced CPAP Mode of ventilation
    Intervention: Device: Respironics OmniLab Advanced CPAP mode
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2012
July 2012   (final data collection date for primary outcome measure)

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 45mmHg
    • AHI > 5
  • Daytime pH > 7.35
  • 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 NPPV
  • Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01368614
HRC-1006-AVAPS-AE-MS
No
Philips Respironics
Philips Respironics
Not Provided
Principal Investigator: Sairam Parthasarathy, MD Southern Arizona VA Healthcare
Principal Investigator: Babak Mokhlesi, MD University of Chicago
Philips Respironics
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP