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Trial registered on ANZCTR


Registration number
ACTRN12621001109897
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Nocturnal supplemental oxygen for obstructive sleep apnoea in patients with fibrotic interstitial lung disease
Scientific title
The effect of nocturnal supplemental oxygen for the management of obstructive sleep apnoea in patients with fibrotic interstitial lung disease
Secondary ID [1] 304788 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial lung disease 322850 0
Obstructive sleep apnoea 322851 0
Condition category
Condition code
Respiratory 320430 320430 0 0
Other respiratory disorders / diseases
Respiratory 320431 320431 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplemental 100% oxygen at 4 litres/min via nasal cannulae during a single night of overnight polysomnography performed by a sleep scientist at a sleep laboratory. Participants who are using CPAP for the management of obstructive sleep apnoea will be temporarily ceasing CPAP for up to 14 days prior to the first night of overnight polysomnography. The two nights of overnight polysomnography will be performed within 4 weeks with at least 1 night in between each study, and a washout period is not required. Participants will be given a pulse oximeter to wear over the fingertip for measurement of overnight oximetry at home over three individual nights without treatment.
Intervention code [1] 321166 0
Treatment: Other
Comparator / control treatment
Spplemental air of 21% oxygen via nasal cannulae during a single night of overnight polysomnography performed by a sleep scientist at a sleep laboratory
Control group
Placebo

Outcomes
Primary outcome [1] 328269 0
Apnoea-hypopnoea index measured by overnight polysomnography
Timepoint [1] 328269 0
During each night of intervention and control exposure
Primary outcome [2] 328272 0
Apnoea-hypopnoea index without desaturation (i.e. flow-based apnoea-hypopnoea index) measured by overnight polysomnography
Timepoint [2] 328272 0
During each night of intervention and control exposure
Secondary outcome [1] 398300 0
Arousal index measured by overnight polysomnography
Timepoint [1] 398300 0
During each night of intervention and control exposure
Secondary outcome [2] 398301 0
Sleep efficiency measured by overnight polysomnography
Timepoint [2] 398301 0
During each night of intervention and control exposure
Secondary outcome [3] 398302 0
Oxygen desaturation index measured by overnight polysomnography
Timepoint [3] 398302 0
During each night of intervention and control exposure
Secondary outcome [4] 398310 0
Nadir oxygen saturation measured by overnight polysomnography
Timepoint [4] 398310 0
During each night of intervention and control exposure
Secondary outcome [5] 399068 0
Percentages of cumulative sleep time with SpO2 < 90% measured by overnight polysomnography
Timepoint [5] 399068 0
During each night of intervention and control exposure
Secondary outcome [6] 399069 0
percentages of cumulative sleep time with SpO2 < 85% measured by overnight polysomnography
Timepoint [6] 399069 0
During each night of intervention and control exposure
Secondary outcome [7] 399070 0
Participant blinding measured by the Bang’s Blinding Index
Timepoint [7] 399070 0
After completion of polysomnographies of the intervention and control exposure
Secondary outcome [8] 399071 0
Stanford Sleepiness Scale
Timepoint [8] 399071 0
During each night of intervention and control exposure
Secondary outcome [9] 399072 0
Serum F2-isoprostanes
Timepoint [9] 399072 0
During each night of intervention and control exposure
Secondary outcome [10] 399073 0
Serum thiobarbituric acid reactive substances
Timepoint [10] 399073 0
During each night of intervention and control exposure
Secondary outcome [11] 399074 0
Serum levels of IL-6
Timepoint [11] 399074 0
During each night of intervention and control exposure
Secondary outcome [12] 399075 0
Serum levels of CRP
Timepoint [12] 399075 0
During each night of intervention and control exposure
Secondary outcome [13] 399076 0
Serum levels of xanthine
Timepoint [13] 399076 0
During each night of intervention and control exposure
Secondary outcome [14] 399077 0
Serum levels of hypoxanthine
Timepoint [14] 399077 0
During each night of intervention and control exposure
Secondary outcome [15] 399078 0
Oxygen Desaturation Index of home overnight oximetry
Timepoint [15] 399078 0
Daily for the duration of 3-day home monitoring without treatment
Secondary outcome [16] 399079 0
Percentages of cumulative sleep time with oxygen saturation < 90% during home overnight oximetry
Timepoint [16] 399079 0
Daily for the duration of 3-day home monitoring without treatment
Secondary outcome [17] 399080 0
Percentages of cumulative sleep time with oxygen saturation < 85% during home overnight oximetry
Timepoint [17] 399080 0
Daily for the duration of 3-day home monitoring without treatment
Secondary outcome [18] 399081 0
Nadir oxygen saturation during sleep during home overnight oximetry
Timepoint [18] 399081 0
Daily for the duration of 3-day home monitoring without treatment

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Able to give written informed consent
3. A multidisciplinary diagnosis of fibrotic interstitial lung disease of any aetiology
4. Suspected obstructive sleep apnoea or confirmed diagnosis of obstructive sleep apnoea using overnight polysomnography
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of or eligible for long-term oxygen therapy
2. Use of respiratory stimulants or depressants
3. Stable health condition (defined as hospitalisation for acute medical conditions) in the last 4 weeks before screening
4. Significant co-existing chronic obstructive pulmonary disease (defined as FEV1/FVC <60% on the most recent lung spirometry or extent of emphysema greater than extent of fibrosis on the most recent CT chest)

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 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
Not yet recruiting
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)
VIC

Funding & Sponsors
Funding source category [1] 309161 0
Charities/Societies/Foundations
Name [1] 309161 0
Centre of Research Excellence in Pulmonary Fibrosis
Address [1] 309161 0
Centre of Research Excellence in Pulmonary Fibrosis, Respiratory Medicine and Sleep Unit, Level 11, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country [1] 309161 0
Australia
Primary sponsor type
Individual
Name
Dr Yet Hong Khor
Address
Institute for Breathing and Sleep
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Country
Australia
Secondary sponsor category [1] 310116 0
None
Name [1] 310116 0
Address [1] 310116 0
Country [1] 310116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309024 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 309024 0
145 Studley Road, Heidelberg 3084, Victoria
Ethics committee country [1] 309024 0
Australia
Date submitted for ethics approval [1] 309024 0
Approval date [1] 309024 0
06/07/2021
Ethics approval number [1] 309024 0

Summary
Brief summary
Obstructive sleep apnoea (OSA) affects more than 50% of people with interstitial lung disease (ILD), with inadequate treatment due to poor compliance with current treatments such as CPAP and mouth splints. Supplemental oxygen is a potential treatment for OSA in people with ILD, which is readily available and easy to use, and ovenight oximetry may be helpful for establishing the diagnosis of OSA in people with ILD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112686 0
Dr Yet Hong Khor
Address 112686 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 112686 0
Australia
Phone 112686 0
+61 39496 3688
Fax 112686 0
Email 112686 0
yethong.khor@austin.org.au
Contact person for public queries
Name 112687 0
Dr Yet Hong Khor
Address 112687 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 112687 0
Australia
Phone 112687 0
+61 39496 5000
Fax 112687 0
Email 112687 0
yethong.khor@austin.org.au
Contact person for scientific queries
Name 112688 0
Dr Yet Hong Khor
Address 112688 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 112688 0
Australia
Phone 112688 0
+61 39496 5000
Fax 112688 0
Email 112688 0
yethong.khor@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For privacy
What supporting documents are/will be available?
No other documents available
Summary results
No Results