Juno Perth Clinical Trial
Juno Perth Clinical Trial
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: To compare sleep and sleep-breathing parameters for patients who use AutoEPAP iVAPS
 (experimental arm) compared to iVAPS (commercially available therapy)

 Participants already established on non-invasive ventilation (NIV) will be recruited to
 participate for 3 nights in a monitored sleep unit. They will have a sleep study each night:

 Night 1 will involve an evaluation of their current NIV settings. Some of these settings will
 be used to set up AutoEPAP iVAPS and iVAPS.

 Night 2 & 3: the participants will be randomised to AutoEPAP iVAPS or iVAPS. They will have
 sleep studies on each therapy, whereby their sleep and sleep-breathing will be monitored and
 evaluated.

 After each night, the participants will be asked to complete a questionnaire about how well
 they slept.

 Phase II: To compare sleep-breathing and therapy adherence for patients who use AutoEPAP
 iVAPS (experimental arm) compared to their usual therapy (Spontaneous Time (ST) mode).

 Participants already established on non-invasive ventilation (NIV; ie. ST mode) will be
 recruited to participate for 14 nights. This study will occur at home. The participants will
 be randomised to trial AutoEPAP iVAPS or ST mode therapy for Week 1 and 2. Data will be
 collected onto the respiratory device (i.e. Juno) detailing objective usage, air leak and
 breathing parameters (e.g. oxygenation). Participants will also complete a questionnaire
 after each week to evaluate subjective sleep quality and comfort.

 Blood samples will also be collected Pre-week 1, and after week 1 & 2 to measure oxygen,
 carbon dioxide and bicarbonate levels in the blood. Blood samples will be taken from the ear
 lobe.
Inclusion Criteria:

 -  Patient has COPD, Obesity Hypoventilation Syndrome or Neuromuscular disease with
 hypercapnia

 -  Clinically established on bilevel therapy for at least 3 months prior to recruitment

 -  Uses < 4 L/min oxygen therapy

 -  Participant has provided informed consent

 Exclusion Criteria:

 -  Patient is non-compliance on bilevel therapy (ie. < 4 hr/night)

 -  Patient has severe asthma,

 -  Patient is pregnant

 -  Patient required

 -  Participant has a tracheostomy

 -  Participant is acutely ill, medically complicated or who are medically unstable

 -  Participants in whom PAP therapy is otherwise medically contraindicated

 -  Participant had surgery of the upper airway, nose, sinus, or middle ear within the
 previous 90 days of recruitment

 -  Participant has untreated, non-obstructive sleep apnea (OSA) sleep disorders