AVAPS-AE Efficacy Study

Completed · Not applicable

Conditions studied: Obesity Hypoventilation Syndrome

In brief

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.

Key facts

Study ID

NCT01368614

Run by

Philips Respironics

People needed

90

Starts

2011-09-12

Expected to finish

2013-05-30

Last updated by the study team

2019-04-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• University of Arizona School of Medicine — Tucson, Arizona, United States
• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.