None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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)