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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02317042




Registration number
NCT02317042
Ethics application status
Date submitted
8/12/2014
Date registered
15/12/2014
Date last updated
8/06/2021

Titles & IDs
Public title
Juno Perth Clinical Trial
Scientific title
The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
Secondary ID [1] 0 0
MA250814
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Insufficiency 0 0
Obesity Hypoventilation Syndrome 0 0
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Neuromuscular Disease 0 0
Upper Airway Obstruction 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Diet and Nutrition 0 0 0 0
Obesity
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Juno
Treatment: Devices - Juno
Treatment: Devices - Juno

Active Comparator: Standard ST Mode - 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.

Experimental: AutoEPAP iVAPS - 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.

Active Comparator: Fixed EPAP iVAPS - 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.


Treatment: Devices: Juno
Juno device set to ST mode with participant's current therapy settings.

Treatment: Devices: Juno
Juno device set to AutoEPAP iVAPS mode.

Treatment: Devices: Juno
Juno device set to Fixed EPAP iVAPS mode.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnoea-Hypopnoea Index (AHI) - The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Timepoint [1] 0 0
1 night
Secondary outcome [1] 0 0
Oxygen Desaturation Index - Number of oxygen desaturations per hour of sleep
Timepoint [1] 0 0
1 night
Secondary outcome [2] 0 0
Mean Oxygen Saturation - Mean oxygen saturation recorded in the total sleep time
Timepoint [2] 0 0
1 night
Secondary outcome [3] 0 0
Time Spent Below 90% Oxygen Saturation - Time in minutes that the oxygen saturation was below 90%
Timepoint [3] 0 0
1 night
Secondary outcome [4] 0 0
Mean Transcutaneous Carbon Dioxide (PtcCo2) - Transcutaneous Carbon Dioxide measurement (TcCO2)
Timepoint [4] 0 0
1 night
Secondary outcome [5] 0 0
Sleep Duration - Time spent asleep
Timepoint [5] 0 0
1 Night
Secondary outcome [6] 0 0
Sleep Efficacy - Sleep time divided by total time available for sleep
Timepoint [6] 0 0
1 Night
Secondary outcome [7] 0 0
Sleep Latency-Wake After Sleep Onset Time - Time awake in minutes after initial sleep onset
Timepoint [7] 0 0
1 Night
Secondary outcome [8] 0 0
Total Sleep Time Spent in Each Sleep Stage - Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Timepoint [8] 0 0
1 Night
Secondary outcome [9] 0 0
Number of Respiratory Event Related Arousals/ Hour - Total number of respiratory event related arousals/hr over the entire sleep period
Timepoint [9] 0 0
1 Night
Secondary outcome [10] 0 0
Number of Spontaneous Arousals/Hour - Number of spontaneous arousals/hr occurring over the entire total sleep time
Timepoint [10] 0 0
1 Night

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [2] 0 0
University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sir Charles Gairdner Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Western Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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)".
Trial website
https://clinicaltrials.gov/show/NCT02317042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02317042