Respiratory InsufficiencyNCT02317042
Juno Perth Clinical Trial
A study testing Juno in people with Respiratory Insufficiency and Obesity Hypoventilation Syndrome, run by ResMed at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Juno
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 May 2015to 29 Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Sir Charles Gairdner Hospital
Perth, Western Australia
University of Western Australia
Perth, Western Australia
About this study
Official title: The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
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)".
Read the detailed description
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.
- Conditions
- Respiratory Insufficiency, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease, Upper Airway Obstruction
- Being tested
- Juno
- Medical subject headings
- Respiratory Insufficiency, Obesity Hypoventilation Syndrome, Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JunoDevice
Also called ResMed "Juno" Device
Juno device set to ST mode with participant's current therapy settings.
JunoDevice
Also called ResMed "Juno" Device
Juno device set to AutoEPAP iVAPS mode.
JunoDevice
Also called ResMed "Juno" Device
Juno device set to Fixed EPAP iVAPS mode.
| Study group | Role | What they receive |
|---|---|---|
| Standard ST Mode | Active comparator | 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. Receives: Device: Juno |
| AutoEPAP iVAPS | Experimental | 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. Receives: Device: Juno |
| Fixed EPAP iVAPS | Active comparator | 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. Receives: Device: Juno |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnoea-Hypopnoea Index (AHI)
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Measured: 1 night
Secondary outcomes (10)
Oxygen Desaturation Index
Number of oxygen desaturations per hour of sleep
Measured: 1 night
Mean Oxygen Saturation
Mean oxygen saturation recorded in the total sleep time
Measured: 1 night
Time Spent Below 90% Oxygen Saturation
Time in minutes that the oxygen saturation was below 90%
Measured: 1 night
Mean Transcutaneous Carbon Dioxide (PtcCo2)
Transcutaneous Carbon Dioxide measurement (TcCO2)
Measured: 1 night
Sleep Duration
Time spent asleep
Measured: 1 Night
Sleep Efficacy
Sleep time divided by total time available for sleep
Measured: 1 Night
Sleep Latency-Wake After Sleep Onset Time
Time awake in minutes after initial sleep onset
Measured: 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)
Measured: 1 Night
Number of Respiratory Event Related Arousals/ Hour
Total number of respiratory event related arousals/hr over the entire sleep period
Measured: 1 Night
Number of Spontaneous Arousals/Hour
Number of spontaneous arousals/hr occurring over the entire total sleep time
Measured: 1 Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study start29 May 2015
- Primary completionNov 2015
- Study completion29 Nov 2015
Why it stopped: Phase II not initiated for commercial reasons (no safety related issues)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sir Charles Gairdner Hospital, The University of Western Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317042
- Sponsor's protocol ID
- MA250814
- Status last verified
- May 2021
- First submitted
- 8 Dec 2014
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
- ClinicalTrials.gov ID
- NCT02317042
- Acronym / sponsor ID
- MA250814
- Conditions
- Respiratory Insufficiency, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease, Upper Airway Obstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase II not initiated for commercial reasons (no safety related issues)
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Sir Charles Gairdner Hospital, The University of Western Australia
- Study start
- 29 May 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 29 Nov 2015 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ST Mode | Active comparator | Device: JunoParticipants 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. |
| AutoEPAP iVAPS | Experimental | Device: JunoParticipants 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. |
| Fixed EPAP iVAPS | Active comparator | Device: JunoParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JunoAlso: ResMed "Juno" DeviceJuno device set to ST mode with participant's current therapy settings. | Device | Standard ST Mode |
| JunoAlso: ResMed "Juno" DeviceJuno device set to AutoEPAP iVAPS mode. | Device | AutoEPAP iVAPS |
| JunoAlso: ResMed "Juno" DeviceJuno device set to Fixed EPAP iVAPS mode. | Device | Fixed EPAP iVAPS |
Primary outcome
Apnoea-Hypopnoea Index (AHI)
Time frame: 1 night
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
10 secondary outcomes
Oxygen Desaturation Index
Time frame: 1 night
Mean Oxygen Saturation
Time frame: 1 night
Time Spent Below 90% Oxygen Saturation
Time frame: 1 night
Mean Transcutaneous Carbon Dioxide (PtcCo2)
Time frame: 1 night
Sleep Duration
Time frame: 1 Night
Sleep Efficacy
Time frame: 1 Night
Sleep Latency-Wake After Sleep Onset Time
Time frame: 1 Night
Total Sleep Time Spent in Each Sleep Stage
Time frame: 1 Night
Number of Respiratory Event Related Arousals/ Hour
Time frame: 1 Night
Number of Spontaneous Arousals/Hour
Time frame: 1 Night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juno in people with Respiratory Insufficiency and Obesity Hypoventilation Syndrome, run by ResMed at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnoea-Hypopnoea Index (AHI) (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.