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Clinical Trial Summary

This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".


Clinical Trial Description

Phase I: AutoEPAP iVAPS will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (Fixed EPAP iVAPS)" in current NIV users with respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD),Obesity Hypoventilation Syndrome (OHS) or Neuromuscular Disease (NMD). Patients will spend a total of 3 nights in the sleep laboratory in the three modes described above. The apnoea-hypopnoea index will be the primary outcome measure. Phase II: AutoEPAP iVAPS will be compared to ST mode over a period of 7 nights in the patients' home. The mean EPAP setting of each device will be the primary outcome measure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02317042
Study type Interventional
Source ResMed
Contact
Status Terminated
Phase N/A
Start date May 29, 2015
Completion date November 29, 2015

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