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)".
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
University of Western Australia
Perth, Western Australia, Australia
Apnoea-Hypopnoea Index (AHI)
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Time frame: 1 night
Oxygen Desaturation Index
Number of oxygen desaturations per hour of sleep
Time frame: 1 night
Mean Oxygen Saturation
Mean oxygen saturation recorded in the total sleep time
Time frame: 1 night
Time Spent Below 90% Oxygen Saturation
Time in minutes that the oxygen saturation was below 90%
Time frame: 1 night
Mean Transcutaneous Carbon Dioxide (PtcCo2)
Transcutaneous Carbon Dioxide measurement (TcCO2)
Time frame: 1 night
Sleep Duration
Time spent asleep
Time frame: 1 Night
Sleep Efficacy
Sleep time divided by total time available for sleep
Time frame: 1 Night
Sleep Latency-Wake After Sleep Onset Time
Time awake in minutes after initial sleep onset
Time frame: 1 Night
Total Sleep Time Spent in Each Sleep Stage
Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Time frame: 1 Night
Number of Respiratory Event Related Arousals/ Hour
Total number of respiratory event related arousals/hr over the entire sleep period
Time frame: 1 Night
Number of Spontaneous Arousals/Hour
Number of spontaneous arousals/hr occurring over the entire total sleep time
Time frame: 1 Night
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.