Trial Outcomes & Findings for Juno Perth Clinical Trial (NCT NCT02317042)
NCT ID: NCT02317042
Last Updated: 2021-06-08
Results Overview
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
1 night
Results posted on
2021-06-08
Participant Flow
An overnight PSG retitration was performed by experienced sleep technologists to ensure current EPAP \& other device settings were optimal. Titration took place with the device in ST mode with the patient's usual therapy setup. If the device settings were not optimal or if other problems such as patient-device dysynchrony, then the ventilator settings were adjusted by the sleep technologist based on current guidelines. Retitration studies were reviewed by at least 2 experienced sleep physicians.
Participant milestones
| Measure |
Standard ST Mode -> AutoEPAP iVAPS -> Fixed EPAP iVAPS
Night 1 Participants underwent the first PSG study on ST Mode 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.
Night 2 Participants underwent a PSG study on the AutoEPAP iVAPS mode Night 3 Participants underwent a PSG study on the Fixed EPAP iVAPS mode
|
Standard ST Mode -> FixedEPAP iVAPS -> AutoEPAP iVAPS Mode
Night 1 Participants underwent the first PSG study on ST Mode 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.
Night 2 Participants underwent a PSG study on the FixedEPAP iVAPS mode Night 3 Participants underwent a PSG study on the AutoEPAP iVAPS mode
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
14
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Juno Perth Clinical Trial
Baseline characteristics by cohort
| Measure |
Participant Baseline
n=25 Participants
Participant's meeting the eligibility criteria had their baseline information collected at their Visit 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 nightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Apnoea-Hypopnoea Index (AHI)
|
3.87 events/hour
Standard Deviation 6.19
|
3.57 events/hour
Standard Deviation 3.76
|
4.09 events/hour
Standard Deviation 5.54
|
SECONDARY outcome
Timeframe: 1 nightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Number of oxygen desaturations per hour of sleep
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Oxygen Desaturation Index
|
5.06 events/hour
Standard Deviation 6.18
|
4.45 events/hour
Standard Deviation 4.15
|
5.70 events/hour
Standard Deviation 8.96
|
SECONDARY outcome
Timeframe: 1 nightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Mean oxygen saturation recorded in the total sleep time
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Mean Oxygen Saturation
|
93.99 percentage of oxygen saturation
Standard Deviation 1.97
|
94.01 percentage of oxygen saturation
Standard Deviation 1.89
|
94.33 percentage of oxygen saturation
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: 1 nightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Time in minutes that the oxygen saturation was below 90%
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Time Spent Below 90% Oxygen Saturation
|
37.26 Minutes
Standard Deviation 78.18
|
37.03 Minutes
Standard Deviation 87.75
|
34.31 Minutes
Standard Deviation 100.25
|
SECONDARY outcome
Timeframe: 1 nightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Transcutaneous Carbon Dioxide measurement (TcCO2)
Outcome measures
| Measure |
Standard ST Mode
n=24 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=24 Participants
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.
|
FixedEPAP iVAPS
n=24 Participants
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.
|
|---|---|---|---|
|
Mean Transcutaneous Carbon Dioxide (PtcCo2)
|
45.73 mmHg
Standard Deviation 6.10
|
47.44 mmHg
Standard Deviation 5.04
|
46.78 mmHg
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: 1 NightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Time spent asleep
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Sleep Duration
|
333.4 Minutes
Standard Deviation 86.06
|
331.7 Minutes
Standard Deviation 109.08
|
340.9 Minutes
Standard Deviation 110.43
|
SECONDARY outcome
Timeframe: 1 NightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Sleep time divided by total time available for sleep
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Sleep Efficacy
|
64 percentage of total recorded time
Standard Deviation 15
|
66 percentage of total recorded time
Standard Deviation 15
|
66 percentage of total recorded time
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 1 NightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Time awake in minutes after initial sleep onset
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Sleep Latency-Wake After Sleep Onset Time
|
22.56 Minutes
Standard Deviation 17.41
|
29.98 Minutes
Standard Deviation 43.19
|
28.12 Minutes
Standard Deviation 29.98
|
SECONDARY outcome
Timeframe: 1 NightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Total Sleep Time Spent in Each Sleep Stage
Time spent in N1 Sleep
|
75.68 Minutes
Standard Deviation 33.88
|
76.62 Minutes
Standard Deviation 45.18
|
82.08 Minutes
Standard Deviation 46.31
|
|
Total Sleep Time Spent in Each Sleep Stage
Time spent in N2 Sleep
|
186.9 Minutes
Standard Deviation 67.14
|
172.3 Minutes
Standard Deviation 74.08
|
174.9 Minutes
Standard Deviation 85.09
|
|
Total Sleep Time Spent in Each Sleep Stage
Time spent in N3 Sleep
|
27.36 Minutes
Standard Deviation 26.43
|
37.38 Minutes
Standard Deviation 31.26
|
29.98 Minutes
Standard Deviation 24.73
|
|
Total Sleep Time Spent in Each Sleep Stage
Time spent in REM Sleep
|
44.04 Minutes
Standard Deviation 26.36
|
45.30 Minutes
Standard Deviation 24.99
|
54.00 Minutes
Standard Deviation 44.10
|
SECONDARY outcome
Timeframe: 1 NightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Total number of respiratory event related arousals/hr over the entire sleep period
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Number of Respiratory Event Related Arousals/ Hour
|
5.17 arousals/hr
Standard Deviation 5.85
|
5.67 arousals/hr
Standard Deviation 4.14
|
6.54 arousals/hr
Standard Deviation 7.69
|
SECONDARY outcome
Timeframe: 1 NightPopulation: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).
Number of spontaneous arousals/hr occurring over the entire total sleep time
Outcome measures
| Measure |
Standard ST Mode
n=25 Participants
Participants underwent the first PSG study (Titration Night 1) on ST Mode 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
n=25 Participants
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.
|
FixedEPAP iVAPS
n=25 Participants
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.
|
|---|---|---|---|
|
Number of Spontaneous Arousals/Hour
|
31.41 arousals/hr
Standard Deviation 21.09
|
29.21 arousals/hr
Standard Deviation 18.16
|
31.92 arousals/hr
Standard Deviation 23.67
|
Adverse Events
Standard ST Mode
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AutoEPAP iVAPS
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
FixedEPAP iVAPS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard ST Mode
n=25 participants at risk
Standard ST mode.
|
AutoEPAP iVAPS
n=25 participants at risk
AutoEPAP iVAPS.
|
FixedEPAP iVAPS
n=25 participants at risk
FixedEPAP iVAPS.
|
|---|---|---|---|
|
General disorders
Multiple Falls
|
0.00%
0/25
|
4.0%
1/25 • Number of events 2
|
0.00%
0/25
|
Other adverse events
| Measure |
Standard ST Mode
n=25 participants at risk
Standard ST mode.
|
AutoEPAP iVAPS
n=25 participants at risk
AutoEPAP iVAPS.
|
FixedEPAP iVAPS
n=25 participants at risk
FixedEPAP iVAPS.
|
|---|---|---|---|
|
General disorders
Discomfort
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Headache
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
AEROPHAGIA
|
8.0%
2/25 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
SORE BACK
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN ABRASION TO CHIN
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
MILD CHEST INFECTION
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
Additional Information
Prof Nigel McArdle & Prof Peter Eastwood
University of Western Australia
Phone: +61 8 9346 1706
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has the right to * review * provide comments (site is not bound to follow them) * request delay of publication for no more than 120 days to allow for securing of IP * request the removal of specified confidential information within 40 days of the proposed publication being released to those not bound by confidentiality obligations.
- Publication restrictions are in place
Restriction type: OTHER