None listed
Conditions
Brief summary
Atrial fibrillation (AF) is estimated to affect at least 0.25 million adult Australians and is the commonest cardiac arrhythmia world-wide. It accounts for an estimated $1.8 billion in annual direct ($1.25B) and indirect ($0.55B) healthcare costs locally. Annual hospital admissions have risen exponentially over the last 15 years, with costs for AF arrhythmia episodes alone in 2008-9 amounting to $430 million. AF causes a substantial lifetime socio-economic burden, as it causes 7,500 ischaemic strokes in Australia each year. Because the risk of stroke is determined largely by the quantitative burden of arrhythmia, treatments to lower arrhythmia burden are critically important. Obstructive sleep apnoea (OSA) is an independent risk factor for AF and more than triples the risk of stroke in AF, over and above other established risk predictors. Up to 80% of patients with AF have OSA. Current AF treatment strategies are ineffective in >50% of cases overall, particularly among individuals with OSA. Observational studies suggest that treatment of OSA may reduce arrhythmia recurrence, but no large RCTs have directly addressed this question. Reducing the >50% arrhythmia recurrence rate may only be possible when combined with structured OSA treatment. This randomised clinical trial is assessing whether routine OSA treatment in addition to a weight management program reduces AF arrhythmia burden.
Interventions
Obstructive sleep apnoea treatment (CPAP or Mandibular advancement splints (MAS) if unable to tolerate CPAP).
Participants allocated to OSA intervention group will have CPAP education and mask fitting session with an experienced sleep technician to fit the CPAP mask followed by an overnight pressure determination study (with measures of sleep and respiration whilst using CPAP) - this is a standard of care test. In the morning the CPAP machine will be set to the pressure that was shown to aboli
Obstructive sleep apnoea treatment (CPAP or Mandibular advancement splints (MAS) if unable to tolerate CPAP). Participants allocated to OSA intervention group will have CPAP education and mask fitting session with an experienced sleep technician to fit the CPAP mask followed by an overnight pressure determination study (with measures of sleep and respiration whilst using CPAP) - this is a standard of care test. In the morning the CPAP machine will be set to the pressure that was shown to abolish obstructive apnoeas and hypopneas as verified by the sleep physician. Participants will be given instructions on how to use a CPAP machine at home and will be encouraged to use their treatment every night for as long as they are able to tolerate its use during the 2 year treatment period.. Regular follow-up during the study at 3-monthly visits will check compliance with the CPAP. If a participant experiences ongoing problems tolerating the CPAP they will be referred to a dentist who will assess whether they are suitable for treatment with MAS. This is a dental splint worn in the mouth every night during sleep to keep the airway open.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Males and females with a history of paroxysmal (at least 2 prior attacks) or persistent AF (<12 months duration [in sinus rhythm at study entry]); 2) Age 18-75; 3) Polysomnography diagnosed OSA of at least moderate severity (AHI >=15); 4) Ability to provide informed consent.
Exclusion criteria
1) Severe OSA related hypoxemia (>10% sleep time with oxygen saturation <80%) and/or awake oxygen saturation less than 92%% 2) Severe respiratory disease (eg Chronic Obstructive Pulmonary Disease or (COPD) 3) Current or prior mechanical treatment for OSA with CPAP or MAS 4) >50% of apnoeas and/or hyponeas associated with Cheyne-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA) 5) Increased risk of sleep-related accident and / or excessive sleepiness defined by any of: * Severe sleepiness as defined by Epworth Sleepiness Scale (>15) * Driver occupation (eg taxi, courier or truck driver) * Sleepiness-related motor vehicle accident, or near accident, within last 12 months prior to enrolment 6) Any relative or absolute contra-indication to CPAP or MAS therapy including chronic cranial injury; recurrent pneumothorax; indication for oral-pharyngeal surgery, edentulous, or loose teeth 7) Any severe other cardiac disease likely to impact ability to comply:
Outcome results
None listed