juno perth clinical trial

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

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)".

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.

Eligibility criteria:
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