Juno Perth Clinical Trial

Not Applicable

Terminated

Conditions: Upper Airway Obstruction
Obesity Hypoventilation Syndrome
Neuromuscular Disease
Respiratory Insufficiency
Chronic Obstructive Pulmonary Disease (COPD)

Brief 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)".

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Apnoea-Hypopnoea Index (AHI)	1 night	The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS

Secondary Outcome Measures

Name	Time	Method
Mean Oxygen Saturation	1 night	Mean oxygen saturation recorded in the total sleep time
Total Sleep Time Spent in Each Sleep Stage	1 Night	Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Number of Respiratory Event Related Arousals/ Hour	1 Night	Total number of respiratory event related arousals/hr over the entire sleep period
Oxygen Desaturation Index	1 night	Number of oxygen desaturations per hour of sleep
Sleep Duration	1 Night	Time spent asleep
Sleep Efficacy	1 Night	Sleep time divided by total time available for sleep
Sleep Latency-Wake After Sleep Onset Time	1 Night	Time awake in minutes after initial sleep onset
Time Spent Below 90% Oxygen Saturation	1 night	Time in minutes that the oxygen saturation was below 90%
Number of Spontaneous Arousals/Hour	1 Night	Number of spontaneous arousals/hr occurring over the entire total sleep time
Mean Transcutaneous Carbon Dioxide (PtcCo2)	1 night	Transcutaneous Carbon Dioxide measurement (TcCO2)

Locations (2): Sir Charles Gairdner Hospital
🇦🇺
Perth, Western Australia, Australia
University of Western Australia
🇦🇺
Perth, Western Australia, Australia
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia