Efficacy of sleep apnoea (OSA) therapy for the reduction of atrial fibrilliation (AF) burden and morbidity in adults with OSA and AF

Phase 3

• Conditions: Atrial Fibrillation; Obstructive Sleep Apnoea; Cardiovascular - Other cardiovascular diseases; Respiratory - Sleep apnoea

• Registration Number: ACTRN12616000903482
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-07
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

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:

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total AF arrhythmia count (cumulative duration of all episodes greater than 30s) quantified using subcutaneous injectable loop recorders (Reveal Linq, Medtronic Inc.) in patients receiving OSA treatment (CPAP or MAS) compared to those receiving no OSA treatment. [Continuous monitoring for 2 years]