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

Arm && Interventions

Group	Intervention	Description
Standard ST Mode	Juno	Participants underwent the first PSG study (Titration Night 1) on ST Mode ( prior to going on AutoEPAP iVAPS or Fixed EPAP iVAPS) whilst receiving their standard NIV therapy through the clinical trial device "Juno". During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy.
Fixed EPAP iVAPS	Juno	Participants underwent a PSG study on the Fixed EPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first.
AutoEPAP iVAPS	Juno	Participants underwent a PSG study on the AutoEPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first.

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