Juno Perth Clinical Trial

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.

• Juno (Device), also known as ResMed "Juno" Device: Juno device set to ST mode with participant's current therapy settings.
• Juno (Device), also known as ResMed "Juno" Device: Juno device set to AutoEPAP iVAPS mode.
• Juno (Device), also known as ResMed "Juno" Device: Juno device set to Fixed EPAP iVAPS mode.

Primary outcomes

• 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 outcomes

• Oxygen Desaturation Index [1 night]: Number of oxygen desaturations per hour of sleep
• Mean Oxygen Saturation [1 night]: Mean oxygen saturation recorded in the total sleep time
• Time Spent Below 90% Oxygen Saturation [1 night]: Time in minutes that the oxygen saturation was below 90%
• Mean Transcutaneous Carbon Dioxide (PtcCo2) [1 night]: Transcutaneous Carbon Dioxide measurement (TcCO2)
• 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
• 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
• Number of Spontaneous Arousals/Hour [1 Night]: Number of spontaneous arousals/hr occurring over the entire total sleep time

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria

* Subject has ability to provide written informed consent
* Subject aged ≥18 years old
* Subject has a diagnosis of COPD, OHS or NMD with sleep hypoventilation (historical PtCO2 increase overnight ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
* Subject is currently using non-invasive ventilation for ≥ 3 months
* Subject with an AHI ≥ 5 hr. (as documented in diagnostic or pressure determination sleep study report)

Exclusion Criteria

* Subjects not compliant on NIV (ie. < 4 hr/night)
* Subjects with severe asthma
* Subjects who are pregnant
* Subjects on oxygen therapy (ie. >4 L/min)
* Subjects with a tracheostomy
* Subjects who are acutely ill, medically complicated or who are medically unstable
* Subjects in whom PAP therapy is otherwise medically contraindicated
* Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
* Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
* Subjects who require ventilatory support during wakefulness
* Subjects with the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, low blood pressure, cerebrospinal fluid leak, recent cranial surgery or trauma.
* Subjects with severe developmental delay and who will not be able to follow tasks as instructed in the protocol.
* Subjects who the investigator believes are unsuitable for inclusion because either:

  * they do not comprehend English
  * they are unable or unwilling to provide written informed consent
  * they are physically unable to comply with the protocol
  * they are unsuitable to participate in the trial for any other reason in the opinion of the investigator

Participant flow

Outcome results

• Apnoea-Hypopnoea Index (AHI) (Primary), Mean, events/hour: Standard ST Mode 3.87 +/- 6.19; AutoEPAP iVAPS 3.57 +/- 3.76; FixedEPAP iVAPS 4.09 +/- 5.54
• Oxygen Desaturation Index (Secondary), Mean, events/hour: Standard ST Mode 5.06 +/- 6.18; AutoEPAP iVAPS 4.45 +/- 4.15; FixedEPAP iVAPS 5.70 +/- 8.96
• Mean Oxygen Saturation (Secondary), Mean, percentage of oxygen saturation: Standard ST Mode 93.99 +/- 1.97; AutoEPAP iVAPS 94.01 +/- 1.89; FixedEPAP iVAPS 94.33 +/- 2.12
• Time Spent Below 90% Oxygen Saturation (Secondary), Mean, Minutes: Standard ST Mode 37.26 +/- 78.18; AutoEPAP iVAPS 37.03 +/- 87.75; FixedEPAP iVAPS 34.31 +/- 100.25
• Mean Transcutaneous Carbon Dioxide (PtcCo2) (Secondary), Mean, mmHg: Standard ST Mode 45.73 +/- 6.10; AutoEPAP iVAPS 47.44 +/- 5.04; FixedEPAP iVAPS 46.78 +/- 6.10
• Sleep Duration (Secondary), Mean, Minutes: Standard ST Mode 333.4 +/- 86.06; AutoEPAP iVAPS 331.7 +/- 109.08; FixedEPAP iVAPS 340.9 +/- 110.43
• Sleep Efficacy (Secondary), Mean, percentage of total recorded time: Standard ST Mode 64 +/- 15; AutoEPAP iVAPS 66 +/- 15; FixedEPAP iVAPS 66 +/- 18
• Sleep Latency-Wake After Sleep Onset Time (Secondary), Mean, Minutes: Standard ST Mode 22.56 +/- 17.41; AutoEPAP iVAPS 29.98 +/- 43.19; FixedEPAP iVAPS 28.12 +/- 29.98
• Total Sleep Time Spent in Each Sleep Stage (Secondary), Mean, Minutes: Standard ST Mode 75.68 +/- 33.88; AutoEPAP iVAPS 76.62 +/- 45.18; FixedEPAP iVAPS 82.08 +/- 46.31
• Number of Respiratory Event Related Arousals/ Hour (Secondary), Mean, arousals/hr: Standard ST Mode 5.17 +/- 5.85; AutoEPAP iVAPS 5.67 +/- 4.14; FixedEPAP iVAPS 6.54 +/- 7.69
• Number of Spontaneous Arousals/Hour (Secondary), Mean, arousals/hr: Standard ST Mode 31.41 +/- 21.09; AutoEPAP iVAPS 29.21 +/- 18.16; FixedEPAP iVAPS 31.92 +/- 23.67

Adverse events

Serious adverse events by term

Other adverse events by term