Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001111460p
Ethics application status
Submitted, not yet approved
Date submitted
26/09/2025
Date registered
13/10/2025
Date last updated
13/10/2025
Date data sharing statement initially provided
13/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Outcomes of Continuous Positive Airway Pressure for Obstructive Sleep Apnoea
Scientific title
Clinical Outcomes of Continuous Positive Airway Pressure for Obstructive Sleep Apnoea in Chinese Adults
Secondary ID [1] 315461 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 339021 0
Condition category
Condition code
Respiratory 335310 335310 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will investigate the sleep and cardiovascular effects of obstructive sleep apnoea treatment (OSA) treatment in Chinese adults, and whether these outcomes differ in those observed in a similar group of Caucasian adults. Adults of Chinese descent (intervention) and Caucasian descent (comparator) with newly diagnosed moderate to severe OSA (apnoea-hypopnoea index (AHI) >15 events/hour) and prescribed CPAP will be recruited. All participants will receive continuous positive airway pressure (CPAP) treatment for the 12-week duration of the study.
CPAP involves using a machine to deliver a continuous flow of pressurized air through a mask to keep the airway open during sleep, used to treat obstructive sleep apnea (OSA). The pressurized air prevents the airway from collapsing, allowing for uninterrupted breathing. CPAP will be used for all periods of sleep including naps over the 12-week study period. The CPAP machine setup and mask fitting will be performed by a CPAP therapist (sleep scientist) for each participant at the start of the 12-week trial.
Sleep, cardiovascular, and metabolic health outcomes will be assessed pre and post CPAP treatment. The primary outcome of this study is change in blood pressure following CPAP treatment, with secondary outcomes including anthropometry, cardiovascular biomarkers, and sleep quality.
CPAP adherence is monitored through data download from the CPAP machine itself, which tracks usage hours, mask leaks, and the pressure setting.
Intervention code [1] 332078 0
Treatment: Devices
Comparator / control treatment
Adults of Caucasian descent with newly diagnosed moderate to severe OSA and prescribed CPAP.
Control group
Active

Outcomes
Primary outcome [1] 342890 0
Blood pressure
Timepoint [1] 342890 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [1] 452569 0
Fasting blood glucose
Timepoint [1] 452569 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [2] 452570 0
Fasting lipids
Timepoint [2] 452570 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [3] 452571 0
Body weight in kg
Timepoint [3] 452571 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [4] 452572 0
Sleepiness
Timepoint [4] 452572 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [5] 452573 0
Sleep quality
Timepoint [5] 452573 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [6] 452574 0
CPAP usage
Timepoint [6] 452574 0
Baseline, 12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Newly diagnosed with moderate to severe Obstructive Sleep Apnoea (AHI>15events/h) and prescribed CPAP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy / breastfeeding
- Had previous weight loss surgery
- history of eating disorders
- using anti-obesity medications
- diagnosis of T1D and insulin-dependent T2D, or any medication that could interfere with weight loss (on acase by case basis),
- renal failure, heart failure, recent MI/stroke (within previous 6months),
- routine shiftwork,
- active psychiatric condition or intellectual disability that would prevent them from following the study protocol.
- Unwilling or unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
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
27/10/2025
Actual
Date of last participant enrolment
Anticipated
27/07/2026
Actual
Date of last data collection
Anticipated
23/10/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 320054 0
Charities/Societies/Foundations
Name [1] 320054 0
Eastern Health Foundation
Country [1] 320054 0
Australia
Primary sponsor type
Individual
Name
A/Professor Denise O'Driscoll - Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 322600 0
None
Name [1] 322600 0
Address [1] 322600 0
Country [1] 322600 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318598 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 318598 0
Ethics committee country [1] 318598 0
Australia
Date submitted for ethics approval [1] 318598 0
26/09/2025
Approval date [1] 318598 0
Ethics approval number [1] 318598 0

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

Contacts
Principal investigator
Name 144666 0
A/Prof Denise O'Driscoll
Address 144666 0
Box Hill Hospital, Level 5, 8 Arnold St, Box Hill, Victoria 3128
Country 144666 0
Australia
Phone 144666 0
+61 3 99756538
Fax 144666 0
Email 144666 0
[email protected]
Contact person for public queries
Name 144667 0
Denise O'Driscoll
Address 144667 0
Box Hill Hospital, Level 5, 8 Arnold St, Box Hill, Victoria 3128
Country 144667 0
Australia
Phone 144667 0
+61 3 99756538
Fax 144667 0
Email 144667 0
[email protected]
Contact person for scientific queries
Name 144668 0
Denise O'Driscoll
Address 144668 0
Box Hill Hospital, Level 5, 8 Arnold St, Box Hill, Victoria 3128
Country 144668 0
Australia
Phone 144668 0
+61 3 99756538
Fax 144668 0
Email 144668 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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Postal address: Sleep Laboratory, Box Hill Hospital, 8 Arnold St, Box Hill, Victoria 3128

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.