Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000225415
Ethics application status
Approved
Date submitted
2/02/2025
Date registered
28/03/2025
Date last updated
28/03/2025
Date data sharing statement initially provided
28/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Nocturnal supplemental oxygen in fibrotic interstitial lung disease
Scientific title
A feasibility trial of nocturnal supplemental oxygen with telemonitoring in fibrotic interstitial lung disease
Secondary ID [1] 313862 0
None
Universal Trial Number (UTN)
Trial acronym
NOTE-FY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial lung disease 336526 0
Obstructive sleep apnoea 336527 0
Condition category
Condition code
Respiratory 333032 333032 0 0
Other respiratory disorders / diseases
Respiratory 333033 333033 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nocturnal supplemental oxygen at a flow rate of 5 L/min via nasal cannula whilst asleep for 2 months. This will be delivered using a oxygen concentrator with telemonitoring for collection of usage data.
Intervention code [1] 330450 0
Treatment: Other
Comparator / control treatment
Medical air (sham) at a flow rate of 5 L/min via nasal cannula whilst asleep for 2 months. This will be delivered using a sham oxygen concentrator with telemonitoring for collection of usage data.
Control group
Placebo

Outcomes
Primary outcome [1] 340578 0
Feasibility of the study design: Number of potential participants screened
Timepoint [1] 340578 0
At the study conclusion (after completion of the final patient recruited for the study)
Primary outcome [2] 340579 0
Feasibility of the study design: Number of potential participants meeting the inclusion criteria
Timepoint [2] 340579 0
At the study conclusion (after completion of the final patient recruited for the study)
Primary outcome [3] 340580 0
Feasibility of the study design: Number of participants recruited
Timepoint [3] 340580 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [1] 444493 0
Feasibility of the study design: Number of participants randomised
Timepoint [1] 444493 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [2] 444494 0
Feasibility of the study design: Number and reasons of participants withdrawn
Timepoint [2] 444494 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [3] 444495 0
Feasibility of the study design: Number of follow-up assessments completed
Timepoint [3] 444495 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [4] 444496 0
Feasibility of the study design: Number of deviations from the study protocol and reasons
Timepoint [4] 444496 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [5] 444497 0
Success of blinding
Timepoint [5] 444497 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [6] 444498 0
Number of participants in each group who would elect to continue using the nocturnal oxygen at the end of the trial
Timepoint [6] 444498 0
At the completion of intervention period (2 months)
Secondary outcome [7] 444499 0
Number of participants in each group who would recommend participating in this trial to others in a similar situation to themselves.
Timepoint [7] 444499 0
At the completion of intervention period (2 months)
Secondary outcome [8] 444500 0
Sleep-specific health-related quality of life
Timepoint [8] 444500 0
At the completion of intervention period (2 months)
Secondary outcome [9] 444501 0
Sleep quality
Timepoint [9] 444501 0
At the completion of intervention period (2 months)
Secondary outcome [10] 444502 0
Fatigue
Timepoint [10] 444502 0
At the completion of intervention period (2 months)
Secondary outcome [11] 444503 0
Dyspnoea
Timepoint [11] 444503 0
At the completion of intervention period (2 months)
Secondary outcome [12] 444504 0
Mood
Timepoint [12] 444504 0
At the completion of intervention period (2 months)
Secondary outcome [13] 444505 0
Cardiac status
Timepoint [13] 444505 0
At the completion of intervention period (2 months)
Secondary outcome [14] 444508 0
Objective sleep quality
Timepoint [14] 444508 0
At the completion of intervention period (2 months)
Secondary outcome [15] 444511 0
Objective sleep quality
Timepoint [15] 444511 0
At the completion of intervention period (2 months)
Secondary outcome [16] 444512 0
Objective sleep quality
Timepoint [16] 444512 0
At the completion of intervention period (2 months)
Secondary outcome [17] 444513 0
Oxygenation status
Timepoint [17] 444513 0
At the completion of intervention period (2 months)
Secondary outcome [18] 444514 0
Nocturnal oxygen therapy usage
Timepoint [18] 444514 0
At the completion of intervention period (2 months)

Eligibility
Key inclusion criteria
1. Age of 18 years and above
2. Able to give written informed consent
3. A multidisciplinary diagnosis of fibrotic interstitial lung disease of any aetiology
4. Suspected or previously known nocturnal hypoxaemia
5. Stable health condition (defined as no hospitalisation for acute medical condition) in the last 4 weeks before screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of or eligible for long-term oxygen therapy (defined as daytime resting SpO2 less than or equal to 88% or daytime resting PaO2 less than or equal to 55 mmHg or PaO2 56-59 mmHg with evidence of hypoxic organ damage [including right heart failure, pulmonary hypertension or polycythaemia])
2. High risk of potential impacts of untreated obstructive sleep apnoea: public transport and truck drivers, heavy machinery workers, those with Epworth Sleepiness Scale of > 17 at the time of screening, and those with a history of motor vehicle accidents in the last 2 years
3. Established treatment with CPAP for OSA

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 concealment will be achieved using sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The generation of a computer-generated random number sequence will be performed by an investigator who will not have direct contact with participants and sleep technicians.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318329 0
Government body
Name [1] 318329 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 318329 0
Australia
Primary sponsor type
Individual
Name
Yet Hong Khor - Austin Health
Address
Country
Australia
Secondary sponsor category [1] 320724 0
None
Name [1] 320724 0
Address [1] 320724 0
Country [1] 320724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316965 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316965 0
Ethics committee country [1] 316965 0
Australia
Date submitted for ethics approval [1] 316965 0
23/08/2024
Approval date [1] 316965 0
13/02/2025
Ethics approval number [1] 316965 0

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

Contacts
Principal investigator
Name 139586 0
A/Prof Yet Hong Khor
Address 139586 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 139586 0
Australia
Phone 139586 0
+61 39496 3688
Fax 139586 0
Email 139586 0
[email protected]
Contact person for public queries
Name 139587 0
Yet Hong Khor
Address 139587 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 139587 0
Australia
Phone 139587 0
+61 39496 3688
Fax 139587 0
Email 139587 0
[email protected]
Contact person for scientific queries
Name 139588 0
Yet Hong Khor
Address 139588 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 139588 0
Australia
Phone 139588 0
+61 39496 3688
Fax 139588 0
Email 139588 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only after de-identification

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator (A/Prof Yet Hong Khor, email address: [email protected])

Are there extra considerations when requesting access to 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.