Stopped: Phase II not initiated for commercial reasons (no safety related issues)
Australia25 participantsStarted 2015-05-29
Plain-language 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)".
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 unsuitab…