Juno Perth Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS

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

Intervention / Treatment
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* Device: Juno
* Device: Juno
* Device: Juno


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard ST Mode<br>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. | Device: Juno<br>* Juno device set to ST mode with participant's current therapy settings.<br>* Other names: ResMed Juno Device;|
| Experimental: AutoEPAP iVAPS<br>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. | Device: Juno<br>* Juno device set to AutoEPAP iVAPS mode.<br>* Other names: ResMed Juno Device;|
| Active Comparator: Fixed EPAP iVAPS<br>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. | Device: Juno<br>* Juno device set to Fixed EPAP iVAPS mode.<br>* Other names: ResMed Juno Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnoea-Hypopnoea Index (AHI) | The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Desaturation Index | Number of oxygen desaturations per hour of sleep | 1 night | 
| Mean Oxygen Saturation | Mean oxygen saturation recorded in the total sleep time | 1 night | 
| Time Spent Below 90% Oxygen Saturation | Time in minutes that the oxygen saturation was below 90% | 1 night | 
| Mean Transcutaneous Carbon Dioxide (PtcCo2) | Transcutaneous Carbon Dioxide measurement (TcCO2) | 1 night | 
| Sleep Duration | Time spent asleep | 1 Night | 
| Sleep Efficacy | Sleep time divided by total time available for sleep | 1 Night | 
| Sleep Latency-Wake After Sleep Onset Time | Time awake in minutes after initial sleep onset | 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) | 1 Night | 
| Number of Respiratory Event Related Arousals/ Hour | Total number of respiratory event related arousals/hr over the entire sleep period | 1 Night | 
| Number of Spontaneous Arousals/Hour | Number of spontaneous arousals/hr occurring over the entire total sleep time | 1 Night |