Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000816459
Ethics application status
Approved
Date submitted
28/08/2024
Date registered
30/07/2025
Date last updated
30/07/2025
Date data sharing statement initially provided
30/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Juno Portable Oxygen Concentrator Evaluation Study in patients with moderate to severe hypoxaemia
Scientific title
A randomized, cross-over, non-inferiority study evaluating Juno, a new type of battery powered continuous flow portable oxygen concentrator vs the current gold standard of compressed cylinder oxygen in patients with moderate to severe hypoxaemia.
Secondary ID [1] 312759 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with moderate to severe hypoxaemia 334804 0
Exertional dyspnea 335289 0
Condition category
Condition code
Respiratory 331362 331362 0 0
Other respiratory disorders / diseases
Respiratory 331363 331363 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Functional status and physiological parameters will be recorded in patients receiving a supplemental oxygen therapy trial from both the Juno portable oxygen concentrator and oxygen cylinder in a randomized, cross over interventional study. Measurements will be recorded by a small electronic data capture device fitted to an elastic strap placed around the chest. This will measure respiratory effort as chest movement with additional measurements of air flow recorded via a nasal cannula and oxygen saturation via a finger probe oximeter, both connected to the chest mounted device. Oxygen delivery is not individualised or titrated to maintain a target saturation, patients will receive a fixed rate of 2L/min of continuous flow oxygen delivered from both the cylinder (approximately 99% purity) and Juno portable oxygen concentrator (approximately 91% purity) for around 16 minutes each, in randomized order. Oxygen will only be delivered for 5 minutes prior to, during the 6 minute walk test and 5 minutes after, for the purposes of assessing the effect of supplemental oxygen on oxygen saturation and walk distance. Oxygen will not be provided beyond the study period unless the patient meets oxygen prescription requirements as usual care, in which case their physician will discuss oxygen cylinder or battery powered concentrator options. Juno is not yet commercially available.

Two 6 minute walk tests will be conducted as a flat walk in an open corridor at the patient's own pace. The two walk tests will be conducted 1 hour apart (or longer if requested) to allow a rest period. The entire trial will take place under direct observation and will be completed in around 2 hours in total (usually completed on the same day)
Intervention code [1] 329294 0
Treatment: Devices
Comparator / control treatment
Current gold standard of continuous flow oxygen cylinder delivery will be compared to the new battery powered portable oxygen concentrator device. The regulator on the portable cylinder delivers a fixed 2L of continuous flow when set in CF mode. The output of the Juno POC is matched to be the same delivery of 2L continuous flow.
Control group
Active

Outcomes
Primary outcome [1] 339227 0
Oxygen saturation
Timepoint [1] 339227 0
Baseline and nadir during 6MWT for both oxygen sources
Primary outcome [2] 339228 0
6 minute walk distance
Timepoint [2] 339228 0
Randomized baseline and follow up walk test with each oxygen source
Secondary outcome [1] 439175 0
Oyxgen device burden and preference
Timepoint [1] 439175 0
Baseline and follow up 6 minute walk tests for each device in randomized order

Eligibility
Key inclusion criteria
18 years of age and over
Resting oxygen saturation 92% or less
Medically suitable for 6 minute walk tests
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Resting oxygen saturation above 92%
Inability to safely complete 6MWT

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
2/07/2024
Date of last participant enrolment
Anticipated
Actual
5/12/2024
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26954 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 43026 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 317189 0
Commercial sector/Industry
Name [1] 317189 0
Roam Technologies Pty Ltd
Country [1] 317189 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Roam Technologies Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319459 0
None
Name [1] 319459 0
Address [1] 319459 0
Country [1] 319459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315934 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 315934 0
Ethics committee country [1] 315934 0
Australia
Date submitted for ethics approval [1] 315934 0
03/11/2023
Approval date [1] 315934 0
29/02/2024
Ethics approval number [1] 315934 0
2023/ETH02545

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136266 0
Mr Jay Flack
Address 136266 0
St George Hospital, Dept of Respiratory Medicine, Ground Floor, Prince William Wing, Kogarah, NSW 2218
Country 136266 0
Australia
Phone 136266 0
+61 291131429
Fax 136266 0
Email 136266 0
[email protected]
Contact person for public queries
Name 136267 0
Lauren Richardson
Address 136267 0
34A Nielsen Avenue, Carlton NSW 2218
Country 136267 0
Australia
Phone 136267 0
+61 408118884
Fax 136267 0
Email 136267 0
[email protected]
Contact person for scientific queries
Name 136268 0
Jay Flack
Address 136268 0
St George Hospital, Dept of Respiratory Medicine, Ground Floor, Prince William Wing, Kogarah, NSW 2218
Country 136268 0
Australia
Phone 136268 0
+61 291131429
Fax 136268 0
Email 136268 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.