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
  Purpose

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.


Condition Intervention
Obesity Hypoventilation Syndrome
Device: AVAPS-AE Mode of Therapy
Device: Respironics OnmiLab BiPAP S mode
Device: Respironics OmniLab Advanced CPAP mode

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVAPS-AE
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368614

Locations
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
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Sairam Parthasarathy, MD Southern Arizona VA Healthcare
Principal Investigator: Babak Mokhlesi, MD University of Chicago
  More Information

No publications provided

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01368614     History of Changes
Other Study ID Numbers: HRC-1006-AVAPS-AE-MS
Study First Received: May 23, 2011
Last Updated: August 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Respironics:
OHS

Additional relevant MeSH terms:
Hypoventilation
Obesity Hypoventilation Syndrome
Respiratory Insufficiency
Apnea
Dyssomnias
Nervous System Diseases
Nutrition Disorders
Obesity
Overnutrition
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on August 27, 2015