Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625001058460
Ethics application status
Approved
Date submitted
12/08/2025
Date registered
24/09/2025
Date last updated
24/09/2025
Date data sharing statement initially provided
24/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Impact of personalized sleep apnoea treatment on atrial fibrillation
Query!
Scientific title
Impact of PerSonaLised ObstrUctive Sleep Apnoea TreatMent On The BurdEn Of AtRial Fibrillation: A randomized study (SLUMBER-AF)
Query!
Secondary ID [1]
315110
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SLUMBER-AF
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea
338518
0
Query!
Atrial Fibrillation
338519
0
Query!
Condition category
Condition code
Respiratory
334824
334824
0
0
Query!
Sleep apnoea
Query!
Cardiovascular
334825
334825
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Obstructive sleep apnoea (OSA) is one of the critical risk factors for atrial fibrillation (AF) which is more common in patients with AF. Overtime if left untreated, it can increase the risk of heart and blood vessel disease including atrial fibrillation.
Participants will be recruited from multiple study sites. Potential participants will be identified by their treating physicians and refer to the research team for consideration in the study. There are 7 clinic visits with the participant over the study period of 15 months. The study aims to determine whether addressing OSA by providing personalised obstructive sleep apnoea treatment (PSAT) has a positive impact on Atrial fibrillation. There will be two arms - Immediate PSAT group (Group 1) and Delayed PSAT group (Group 2). Group 1 will receive PSAT for first 12 months and Group 2 in the latter 6 months. Each clinic visit is estimated 45 minutes each and will involve a blood test, echocardiography and download of heart and sleep data. Also participant will be reviewed for their adherence of CPAP or MAS device, and alternative treatment will be given if there is evidence of reduced compliance as personalized therapy.
Participant will undergo implantable loop recorder (ILR) insertion for objective evaluation of AF burden. This is a standard of care for management of AF, and it allows to monitor heart’s electrical activity continuously.
After 1 month of baseline AF monitoring, participant will be randomized into either an immediate personalised sleep apnoea (PSAT) treatment group (Group 1) or delayed personalised sleep apnoea treatment group (Group 2).
Group 1 will undergo treatment based on current sleep apnoea guideline (AASM, 2019) and personal preference which will either be Continuous Positive Airway Pressure (CPAP) machine or Mandibular Advancement Splint (MAS) device.
CPAP therapy involves nightly use of CPAP machine (Resmed Airsense 10 Autoset) via a mask during sleep which is worn over the nose/mouth. It provides continuous positive airway pressure to physiologically splint the upper airway to prevent collapse. MAS device (SomnoMed Avant) is custom fitted oral appliance worn each night during sleep inside the mouth to move the jaw forward during the sleep to prevent collapse of the upper airway.
Group 1 will be reviewed for their adherence of personalized therapy at 1 month after initiation with CPAP download data and participant diary/device data logs with MAS device. There after participant can be reviewed as needed basis if required (either as telehealth or face to face consultation). If participant has difficulty adhering to their initial personalized therapy after 1 month trial, they can be offered to switch to alternative therapy as CPAP or MAS device. If over the study period, participant has persistent difficulty adhering to either treatments, they can be trialed on combination therapy with combined CPAP and MAS device or refer to their sleep physician for further management.
After 7 months into the study, all groups will be re-evaluated of AF burden for 1 month by monitoring loop recorder and repeating the tests that were performed at the start. After this period, Group 2 will commence personalised sleep apnoea treatment, same treatment as Group 1 (either CPAP or MAS device) with the same process.
At the completion of study, AF burden will be re-evaluated again in both groups and other tests will be repeated.
Query!
Intervention code [1]
331731
0
Early detection / Screening
Query!
Intervention code [2]
331732
0
Treatment: Devices
Query!
Intervention code [3]
331733
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
If a participant is randomized into Group 2, they will initially undergo conservative management including written advice about lifestyle modification (e.g. weight loss, sleep hygiene and minimisation of sedatives) followed by commencing personalized sleep apnoea therapy after 7 months into the study.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
342459
0
Change in AF burden
Query!
Assessment method [1]
342459
0
Assess from implantable loop recorder: minutes in AF and percentage of AF
Query!
Timepoint [1]
342459
0
Baseline and 6 months after personalized therapy.
Query!
Secondary outcome [1]
450897
0
Change in AF burden at 15 months in the treatment group compared with control group.
Query!
Assessment method [1]
450897
0
Assess from implantable loop recorder: minutes in AF and percentage of AF
Query!
Timepoint [1]
450897
0
Baseline and 12 months after personalized therapy.
Query!
Secondary outcome [2]
450898
0
Change in left atrial area.
Query!
Assessment method [2]
450898
0
Measuring cardiac parameters with transthoracic echocardiograph
Query!
Timepoint [2]
450898
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [3]
450899
0
Change in AF symptom score compared to control
Query!
Assessment method [3]
450899
0
Atrial Fibrillation Effect on Quality of Life Score
Query!
Timepoint [3]
450899
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [4]
450900
0
Overall quality of life compared to control
Query!
Assessment method [4]
450900
0
Patient Questionnaire - Short Form Health Survey (SF-36)
Query!
Timepoint [4]
450900
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [5]
450901
0
Changes in inflammatory biomarker
Query!
Assessment method [5]
450901
0
Measure hsCRP from blood sample
Query!
Timepoint [5]
450901
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [6]
451384
0
Change in right atrial area
Query!
Assessment method [6]
451384
0
Transthoracic Echocardiography
Query!
Timepoint [6]
451384
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [7]
451385
0
Change in left atrial strain
Query!
Assessment method [7]
451385
0
Transthoracic Echocardiography
Query!
Timepoint [7]
451385
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [8]
451386
0
Change in left ventricular ejection fraction
Query!
Assessment method [8]
451386
0
Transthoracic Echocardiography
Query!
Timepoint [8]
451386
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [9]
451387
0
Change in Left Ventricular End-Diastolic Dimension (LVEDD)
Query!
Assessment method [9]
451387
0
Transthoracic Echocardiography
Query!
Timepoint [9]
451387
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [10]
451388
0
Change in Left Ventricular (LV) strain
Query!
Assessment method [10]
451388
0
Transthoracic Echocardiography
Query!
Timepoint [10]
451388
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [11]
451389
0
Change in Pulmonary Arterial Systolic Pressure (PASP)
Query!
Assessment method [11]
451389
0
Transthoracic Echocardiography
Query!
Timepoint [11]
451389
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [12]
452242
0
Change in AF symptom score compared to control
Query!
Assessment method [12]
452242
0
Mayo AF Specific Symptom Inventory
Query!
Timepoint [12]
452242
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [13]
452243
0
European Heart Rhythm Association Symptom Score
Query!
Assessment method [13]
452243
0
Change in AF symptom score compared to control
Query!
Timepoint [13]
452243
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [14]
452483
0
Changes in inflammatory biomarker
Query!
Assessment method [14]
452483
0
Measure IL-6 from a blood sample.
Query!
Timepoint [14]
452483
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [15]
452484
0
Changes in inflammatory biomarker
Query!
Assessment method [15]
452484
0
Measure TNF-a from a blood sample
Query!
Timepoint [15]
452484
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [16]
452485
0
Changes in cardiac biomarker
Query!
Assessment method [16]
452485
0
Measure hs-Troponin from a blood sample
Query!
Timepoint [16]
452485
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [17]
452486
0
Changes in cardiac biomarker
Query!
Assessment method [17]
452486
0
Measure NT-proBNP from a blood sample.
Query!
Timepoint [17]
452486
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [18]
452487
0
Changes in endocrine biomarkers
Query!
Assessment method [18]
452487
0
Measure HbA1C from a blood sample
Query!
Timepoint [18]
452487
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [19]
452488
0
Changes in endocrine biomarker
Query!
Assessment method [19]
452488
0
Measure HDL/LDL from a blood sample.
Query!
Timepoint [19]
452488
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [20]
452489
0
Changes in endocrine biomarker
Query!
Assessment method [20]
452489
0
Measure insulin from a blood sample
Query!
Timepoint [20]
452489
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [21]
452490
0
Changes in endocrine biomarker
Query!
Assessment method [21]
452490
0
Measure SHBG from a blood sample.
Query!
Timepoint [21]
452490
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [22]
452491
0
Changes in endocrine biomarker
Query!
Assessment method [22]
452491
0
Measure changes in TSH/FT4 from a blood sample
Query!
Timepoint [22]
452491
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [23]
452492
0
Changes in endocrine biomarker
Query!
Assessment method [23]
452492
0
Measure leptin from a blood sample
Query!
Timepoint [23]
452492
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [24]
452493
0
Changes in haemodynamic markers
Query!
Assessment method [24]
452493
0
Measure renin from a blood sample.
Query!
Timepoint [24]
452493
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Secondary outcome [25]
452494
0
Changes in thrombogenesis biomarker
Query!
Assessment method [25]
452494
0
Measure Procollagen Type 3 Intact N-Terminal Propeptide (P3NP) from a blood sample.
Query!
Timepoint [25]
452494
0
Baseline, 6 months after personalized therapy and 12 months after personalized therapy.
Query!
Eligibility
Key inclusion criteria
i. 18 years of age or over
ii. Diagnosis of paroxysmal atrial fibrillation
iii. Moderate or severe Obstructive Sleep Apnoea - Apnoea Hypopnea Index (AHI) of 15 or greater. AHI is a measurement of obstructive sleep apnoea severity, with a higher AHI indicating more severe sleep apnoea.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Permanent/persistent AF
- Life expectancy less than 2 years
- Pregnancy
- Reversible cause for AF (Examples include: thyrotoxicosis, sepsis etc)
- Unable to consent
- Previous sleep apnoea therapy
- Presence of central sleep apnoea (Greater than 20% of overall AHI)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. REDCap Database)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Observational data suggest that CPAP therapy results in a 40% absolute risk reduction of recurrent AF at 1 year follow up (42% vs 82%). Adopting a conservative treatment effect of 25%, based on an a error of 0.05 and ß error 0.2 power calculation, we estimate that we will require 50 participants per group (n=100). Accounting for 20% dropout rate, we will aim to recruit 120 participants (n=60 per group).
All analysis will be performed off-line with investigators blinded to patient group, sleep apnoea severity or treatment status. AF burden (% and time in AF) will be available via the loop recorder. Participants with personalised sleep apnoea treatment; on CPAP treatment, the residual AHI will also be recorded together with the hours of therapy on compliance. These measures are available from the CPAP downloads that participants clinically use. For those on MAS therapy, hours of use will be downloaded from their device. These parameters will be used to determine the impact of personalised sleep apnoea treatment with AF burden.
The primary endpoint of reduction of AF burden will be evaluated using a generalized mixed repeated-measures model, including baseline and post-intervention observations for each participant parameterized to identify the period and the randomized condition in the post-treatment period. The stratification factor (AHI 15-30 versus AHI?30) and BMI (>30 versus <30) will be included in this and all other statistical models for pre-specified outcomes. We will perform both an intention-to-treat analysis and an on-treatment analysis based on participant compliance. Data will be summarized and presented as means with standard deviations or medians with inter-quartile-range for continuous variables and as absolute numbers and percentages for categorical data.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
6/10/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
319684
0
Government body
Query!
Name [1]
319684
0
Investigator initiated grant - NSW Health
Query!
Address [1]
319684
0
Query!
Country [1]
319684
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Macquarie Univerisity
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
322190
0
None
Query!
Name [1]
322190
0
Query!
Address [1]
322190
0
Query!
Country [1]
322190
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
318247
0
Northern Sydney Local Health District Human Research Ethics Committee
Query!
Ethics committee address [1]
318247
0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
Query!
Ethics committee country [1]
318247
0
Australia
Query!
Date submitted for ethics approval [1]
318247
0
22/02/2025
Query!
Approval date [1]
318247
0
04/07/2025
Query!
Ethics approval number [1]
318247
0
Query!
Summary
Brief summary
Atrial fibrillation (AF) is the most common chronic heart rhythm problem and controlling risk factors are pivotal in management. Obstructive Sleep Apnoea (OSA) has emerged as an independent risk factor for AF and is defined by repetitive airway obstruction during sleep which overtime gives rise to AF. Conventional therapy is Continuous Positive Airway Pressure (CPAP) which is worn during sleep to prevent airway collapse. However, CPAP therapy is not all tolerated and Mandibular advancement splints (MAS) device has emerged as alternative therapy to CPAP. Customized MAS is worn during sleep which repositions the jaw anteriorly to keep airway patent. This study aims to evaluate the impact of patient centred approach in management of OSA on AF burden.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
143562
0
A/Prof Chrishan Nalliah
Query!
Address
143562
0
Department of Cardiology, Macquarie University Hospital, 3 Technology Place, Macquarie University New South Wales 2109
Query!
Country
143562
0
Australia
Query!
Phone
143562
0
+61 02 9462 9777
Query!
Fax
143562
0
Query!
Email
143562
0
[email protected]
Query!
Contact person for public queries
Name
143563
0
Dong Seok Yi
Query!
Address
143563
0
Department of Respiratory Medicine, Royal North Shore Hospital, Reserve Road, ST. LEONARDS New South Wales 2065
Query!
Country
143563
0
Australia
Query!
Phone
143563
0
+61 02 9926 7111
Query!
Fax
143563
0
Query!
Email
143563
0
[email protected]
Query!
Contact person for scientific queries
Name
143564
0
Dong Seok Yi
Query!
Address
143564
0
Department of Respiratory Medicine, Royal North Shore Hospital, Reserve Road, ST. LEONARDS New South Wales 2065
Query!
Country
143564
0
Australia
Query!
Phone
143564
0
+61 02 9926 7111
Query!
Fax
143564
0
Query!
Email
143564
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
HREC Ethics Approval Letter - 2025ETH00388_04Jul2025.pdf
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.
Download to PDF