TerminatedNot Applicable

Juno Perth Clinical Trial

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 range

18 Years – 80 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Apnoea-Hypopnoea Index (AHI)

Timeframe: 1 night

Trial details

NCT IDNCT02317042

SponsorResMed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2017-05-14

View on ClinicalTrials.gov More Respiratory Insufficiency trials