Does obstructive sleep apnoea treatment improve heart rhythm control in patients after having an Atrial Fibrillation ablation. A randomised controlled trial

This is a multi centre interventional prospective randomised controlled study that aims to evaluate whether patients diagnosed with moderate to severe obstructive sleep apnoea (OSA) have an improvement in AF recurrence with treatment of OSA following ablation therapy for Atrial Fibrillation (AF). Patients who meet eligibility criteria pending sleep diagnosis of sleep disordered breathing (SDB) will be screened using the ambulatory WatchPAT device. Patients with a study demonstrating moderate to severe predominant OSA (AHI =(equal to or greater than) 15; central apnoea index/total apnoea index <20%) will be randomised to treatment or observational management. Patient randomised to the treatment arm will commence Continuous Positive Airway Pressure (CPAP) therapy while patients in the observational arm will not. CPAP therapy will commence within 3 months of WatchPAT study (window period of CPAP commencement is within 2 months prior to ablation to 3 months post ablation). Patients will attend the Sleep Laboratory at the participating site to be fitted and provided with a loan Auto Positive Airway Pressure (APAP) device to allow for implementation and titration of pressures (can range from 1-4 weeks). Once titration settings have been stabilized and achieved, patients will return to the sleep laboratory at the participating site and be fitted with a fixed pressure Continuous Positive Airway Pressure (CPAP) machine by the CPAP therapist and will receive CPAP education, mask fitting and acclimatization prior to titration. This may take approximately 2-3hours. CPAP machines will have data chips for remote monitoring of pressures by central core sleep lab and patients sleep physician to reduce burden on patients visiting sites. Education for CPAP device will be available and provided by the study core sleep lab at any time throughout the study. Patients will be required and encouraged to use the CPAP machine for a period of 12 months post AF ablation. After a minimum of 1 month continuous treatment from implementation date, if adherence by documented CPAP use cannot be achieved for a minimum of 4 hours per night for at least 5 nights per week despite review and further encouragement, alternate therapy will be prescribed. Sponsored therapies allowed include a mandibular advancement device or sleep re-positional therapy devices which must be implemented within 3 months post ablation date (during the patients blanking period). Patients will have access to the central core sleep lab technicians for any troubleshooting and questions. Patients randomised to the control group will not receive CPAP therapy or other OSA treatment modalities for the study period unless medically indicated. Post randomisation, all patients (treatment arm and control arm) will have repeated sleep study monitoring using the WatchPAT device at 3, 6 and 12 months. All monitoring will be reviewed by a central sleep core lab. The central sleep core lab is available throughout the study for patient education. Patients will also receive a Itamar Medical WatchPAT educational booklet and youtube video on how to use the device at each WatchPAT timepoint. The Ablation procedure is standard of care treatment and there is no alteration of the clinical procedure as part of the study protocol. Ablation procedure is completed as standard of care treatment and not a study related procedure. All patients will receive an implantable loop recorder or a mobile rhythm monitoring device at the discretion of the treating investigator for heart rhythm monitoring. Implantable loop recorders will be inserted and used as standard of care practice as per each hospital protocols. All patients will undergo 24hr Holter monitoring at 3, 6 and 12 months.